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A Study to Assess Emotional Experiences in Patients with Symptomatic Heart Failure and Left Ventricular Assist Devices
Rochester, MN
The objectives of this study are to use qualitative methods to characterize patients’ distress, to use qualitative methods to explore how distress can impact healthcare behaviors and caregiver support; specifically, their motivation to sustain critical lifestyle changes and provide assertive communication with caregivers and medical teams, and to use qualitative methodology to explore if themes found in patients with symptomatic heart failure (HF) translate to patients with left ventricular assist devices (LVAD) or if they will be superseded by LVAD-specific themes.
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Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction
La Crosse, WI
This study is being done to study how well the heart contracts and relaxes during exercise. In addition to traditional measures of heart function, we will use a new computer program that may improve understanding of why people feel shortness of breath or fatigue.
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A Study to Determine Factors in Recruiting Lung Surface Area for Gas Exchange during Exercise in HFpEF Patients
Rochester, MN
This study will determine what factors are involved in recruiting lung surface area for gas exchange during exercise in HFpEF patients, providing insight into the relationship between lung diffusing capacity and pulmonary vascular pressures.
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Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network (ROSE) Study
Rochester, MN
The purpose of this study is to determine the benefits and safety of intravenous administration of low dose nesiritide or low dose dopamine in patients with congestive heart failure and kidney dysfunction.
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Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
La Crosse, WI; Jacksonville, FL
CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.
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A Study to Compare the Quality of Life of Patients Who Have Had Both an LVAD and then a Heart Transplant
No Locations
The purpose of this study is to compare the experienced quality of life of patients who have received both a left ventricular assist device (LVAD), followed by a heart transplant and to measure the results.
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Detection of Reduced Left Ventricular Ejection Fraction with Single Lead ECG Using Artificial Intelligence
Rochester, MN
The purpose of this study is to modify and adapt the algorithm to be usable in a mobile form factor with a limited number of leads. For this, will prospectively test and validate the adapted algorithm in outpatients presenting to the echocardiography laboratory and to test the sensitivity and specificity of a single lead ECG to identify people with decreased left ventricular EF.
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A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
Rochester, MN
The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of 3 dose levels of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.
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Hand-Held Echocardiography in Heart Failure by APPs
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the use of Hand-Held Echocardiography (HHE) as a diagnostic tool and extension of physical assessment by trained Advanced Practice Providers (APPs) in patients admitted with congestive heart failure (CHF) in comparison to that of an expert
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Exhaled Biomarkers for Heart Failure
Rochester, MN
The pilot study aims to recruit 60 subjects classified as New York Heart Assosciation (NYHA) class 1-2 HF patients (n = 15), NYHA class 2-3 HF patients (n = 15), HF patients admitted to the emergency room for treatment of fluid overload (n = 15), and healthy controls (n = 15). Breath samples will be collected form these patients using a ReCIVA Breath Sampler (Owlstone Medical Ltd.) to determine the levels of exhaled volatile organic compounds (VOCs). Following enrollment and study completion, study staff will access the participants’ clinic records to obtain information about their NYHA classification, blood biomarker levels, excess fluid status, ...
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Brain and Cognition Effects of Cardio Resynchronization Therapy in Heart Failure
Jacksonville, FL
The purpose of this research study is to understand the effects of changes in the capability of the heart on brain function so that we can better predict who will most benefit from cardio-resynchronization therapy (CRT) and how it may enhance brain health.
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Clinical Use of the Impella RP System
Rochester, MN
This Is a Humanitarian Use Protocol for the Impella RP® System which is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
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A Study of the SynCardia Temporary Total Artificial Heart Used as End Point Therapy
Rochester, MN
The purpose of this study is to evaluate whether the Temporary Total Artificial Heart can support patients with life-threatening irreversible biventricular heart failure who are not eligible for transplantation.
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Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
Rochester, MN
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.
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Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency
Jacksonville, FL
The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction.
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Transapical and Transfemoral TAVR, Two Different Patient Populations with Possible Similar Clinical and Cardiac Mechanics Outcomes
Rochester, MN
Compare transapical and transfemoral TAVR as regards clinical outcomes (both beneficial including improvement in heart failure class (NYHA) and reduced number of hospitalizations; and adverse including mortality and MACE.) Also, to compare cardiac mechanics’ outcomes in the short and intermediate follow up and correlate the baseline, percent change and final cardiac mechanics values with the clinical outcomes. So that this all comes down to being able to provide these information to the patients if there appeared to be a correlation between cardiac mechanics and clinical outcomes:
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Circulating NEP and NEP Inhibition Study in Heart Failure With Preserved Ejection Fraction
Rochester, MN
To determine biomarker responses to Entresto™in patients with Heart Failure with preserved Ejection Fraction (HFpEF) and who have high or low serum neprilysin (NEP) levels.
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Cost-Effective Strategies to Improve Rehabilitative Medicine for Heart Failure Patients with Preserved Ejection Fraction
Scottsdale/Phoenix, AZ
Thte purpose of this study is to determine the impact of acute interval-style exercise training, with or without essential amino acid ingestion, on markers of muscle turnover and mitochondrial biogenesis. The study also aims to determine the impact of acute interval-style exercise training, with or without essential amino acid ingestion, on skeletal muscle satellite cell and myonuclei content.
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Treating Patients with Heart Failure Using a Respiratory Resistance Therapeutic Device
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the potential benefits to pulmonary function using a unique respiratory “training mask” during exercise on patients with heart failure.
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A Study Evaluating a Decision Support Tool for Patients and Caregivers Offered a Heart Assist Device for End Stage Heart Failure
Rochester, MN
The purpose of this study is to evaluate the effectiveness and implementation of a new shared decision support tool. Using feedback from patients, caregivers, and clinicians, a paper and video decision aid has been made to help people who are offered DT LVAD (a partial artificial heart—so-called destination therapy left ventricular assist device) make this most difficult of decisions. Although patients may live longer with a DT LVAD, it poses many risks, including stroke, serious infection, and bleeding.Unlike the information that is now available, our decision aid focuses on options, fears, and the needs of caregivers, is balanced, and is paired with ...
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A Study of Mechanisms of Altered Ventilatory Control in Heart Failure
Rochester, MN
This study is being done because the investigators are trying to understand how feedback from the muscles can influence your blood pressure and breathing during exercise, and if the investigators can reduce this response in heart failure patients. The investigators are also trying to determine ways to improve tolerance to exercise in heart failure patients.
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Right Ventricular and Physiologic Cardiac Pacing on Left Ventricular Systolic and Diastolic Function by Cardiopulmonary Exercise Testing to Treat Normal Baseline Left Ventricular Ejection Fraction
Scottsdale/Phoenix, AZ
Right ventricular (RV) pacemaker dependent patients without left ventricular (LV) systolic or diastolic dysfunction at baseline will demonstrate worse LV diastolic and systolic function and pulmonary gas exchange reserve during exercise stress compared to patients with physiologic pacing.
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Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure
Rochester, MN
The primary hypothesis is that patients with HFREF (heart failure with reduced ejection fraction) will demonstrate a markedly expanded intravascular volume which will correlate with elevated right heart hemodynamics and increased venous capacitance parameters, whereas patients with HFPEF(heart failure with preserved ejection fraction) will demonstrate euvolemia to mild volume expansion and a lack of correlation with hemodynamic and venous compliance parameters.
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A Study to Evaluate the Safety and Effectiveness of Allogeneic Mesenchymal Precursor Cells for the Treatment of Heart Failure
Rochester, MN
The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.
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A Study to Evaluate Home Monitoring of Post-Discharge Congestive Heart Failure Patients
Rochester, MN
The primary purpose of this study is to collect long-term (2-month duration) data with the ADI CHF Device on patients at home to demonstrate effectiveness of the device in accurately measuring biologically relevant parameters and detecting fluid status as compared to the standard of care (weight scale).
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Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
Rochester, MN
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
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Peripheral Neural Mechanisms of Exercise Intolerance in Heart Failure
Rochester, MN
The goal of this project is to study mechano- and- metaboreceptor function (mechanoreflex and metaboreflex, respectively) associated with exercise in HF. We will measure blood pressure, systemic vascular resistance (SVR), and the slope of the ventilatory equivalent to carbon dioxide output ratio (VE/VCO2) slope responses to stimulation of these pathways. We also aim to determine the influence of changes in blood biochemistry and intra-venous pressure on mechano- and- metaboreflex activation.
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His Bundle Pacing in Bradycardia and Heart Failure
Rochester, MN
Participants in this study will either have heart failure (HF) and are scheduled to undergo cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D) implantation, or have atrioventricular (AV) block and are scheduled to undergo dual chamber pacemaker implantation. In this study additional heart rhythm measurements will be collected during the implant procedure to better understand how His bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of patients with HF or AV block. The hypothesis is that His bundle or parahisian pacing (HISP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q ...
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Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)
Rochester, MN
The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.
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Non-Invasive Monitoring of Potassium Levels in Patients with Congestive Heart Failure
Rochester, MN
The purpose of this study is to examine that signal processed ECGs can be used to monitor changes in serum concentrations of potassium based on T-wave features.
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Study of Hemodynamic-GUIDEd Management of Heart Failure
Rochester, MN
The purpose of this GUIDE-HF IDE clinical trial is to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
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A Study to Assess Blood Flow (Hemodynamics) of Patients with Cardiac Pacemakers
Rochester, MN
The purpose of this study is to determine how changes in pacemaker rate affect systemic hemodynamics, including blood pressure and cardiac output, in acutely ill patients with cardiac pacemakers.
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A Study of the Effectiveness and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients with Preserved Ejection Fraction
Rochester, MN
The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients who have HF with preserved ejection fraction.
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Hospital Diuretic Therapy and Associated Risk of Heart Failure in Treating Fluid Volume Overload
Rochester, MN
The objective of this proposal is to assess blood-plasma volume (TBV-PV) status quantitatively in patients with DHF admitted to hospital for volume management, and to determine how effective standard diuretic therapy is in achieving euvolemia and the impact of their quantitated volume status at the time of hospital discharge on heart failure related morality and re-hospitalizations. Thus, to determine if quantitative blood volume analysis could potentially serve as an effective tool to guide more effective in-hospital diuretic therapy to achieve better outcomes in patients hospitalized with clinically identified volume overload.
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EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study)
Rochester, MN
The primary objective of the study is to determine whether, in patients with symptomatic, advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696 for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect hemodynamic and clinical status, compared to treatment with valsartan.
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Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
Rochester, MN
Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study will assess the effects of acute nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred to the catheterization lab.
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Safety Study of Chimeric Natriuretic Peptide(CD-NP) in Stable LVAD Patients
No Locations
The most promising chimeric natriuretic peptide designed and studied by our group has been CD-NP which has anti-fibrotic and cardioprotective properties in vivo, vitro and in normal volunteers and human heart failure patients. Since left ventricular assist device (LVAD) can not reverse remodeling of the heart whereas it can improve hemodynamics, CD-NP may be novel anti-fibrotic and anti-remodeling drug as co-therapy during LVAD support.
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Hemodynamic Effects of a Novel Myeloperoxidase Inhibitor with Exercise in Heart Failure with Preserved Ejection Fraction
Rochester, MN
The purpose of this study is to determine the effect of a single dose of an oral acute MPO inhibitor drug on resting and exercise hemodynamics (arterial blood pressure and cardiac blood flow) in patients with heart failure with preserved ejection fraction (HFpEF).
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RESPONDER-HF Trial
Rochester, MN
The purpose of this study is to further evaluate the clinical effectiveness of the Corvia Atrial Shunt in symptomatic heart failure patients with a left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard GuidelineDirected Medical Therapy (GDMT); and to confirm the treatment effect observed in the responder group of the REDUCE LAP-HF Randomized Trial II.
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Early Feasibility Study - Transcatheter Atrial Shunt System
Rochester, MN
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
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IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients
Rochester, MN
The main objective of this study to assess the quality of the ECG readings between different filters from both the GE machine and the Smartheart device.
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Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot
Rochester, MN
The Pilot study is designed to evaluate the overall safety and feasibility of a strategy based on subcutaneous delivery of furosemide. It will be used to inform the subsequent evaluation phase of the study (separate protocol). The primary objective of the study is to determine if a strategy of a novel subcutaneous delivery of furosemide is safe and feasible in patients with acute heart failure.
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A Study of Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Rochester, MN
The purpose of this study is to demonstrate acute effectiveness and safety of minimally-invasive pericardiotomy in patients with Heart Failure (HFpEF).
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A Study to Evaluate Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure with Preserved Ejection Fraction
Rochester, MN
The objective of this clinical evaluation is to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).
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Alterations of Pulmonary Vascular System in Patients Supported By Continuous Flow Left Ventricle Assist Device (LVAD)
Rochester, MN
The purpose of this study is to assess the impact of continuous-flow Left Ventricle Assist Device (LVAD) therapy and total artificial heart (TAH) therapy on the alveolar-capillary interface and bronchial circulation of lungs in patients with heart failure (HF).
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A Study to Adapt a Measure of Heart Failure to an Adolescent Population
Rochester, MN
The purpose of this study is to understand the experience of heart failure symptoms on the adolescent patient population, including the impact of symptoms on quality of life and wellbeing.
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A Study to Evaluate Dapagliflozin to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure
Rochester, MN
The purpose of this international study is to evaluate the effect of dapagliflozin 10 mg versus placebo in HFpEF patients, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.
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A Study of After Exercise Mechanical Dyssynchrony and Acute Response to Cardiac Resynchronization Therapy in Patients with Congestive Heart Failure
Rochester, MN
The purpose of this study is to assess the presence and severity of mechanical dyssynchrony in patients with congestive heart failure (CHF) when selecting to CRT in resting and after-exercise echocardiography by multiple echocardiographic techniques, and to evaluate association of exercise-induced mechanical dyssynchrony with acute response to CRT.
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A Study to Evaluate Breathing Muscle Training in Cardiac Rehab
Rochester, MN
We are currently enrolling both healthy volunteers and people who have been diagnosed with heart failure to participate in our research study. The purpose of this study is to better understand the relationship between exercise, breathing, blood flow and blood pressure. This study includes two study visits if you are a healthy or heart failure volunteer. All testing will be performed at our testing center at St. Mary’s Hospital located in Rochester, MN.
On the first study visit, the research activities will be discussed and all questions will be answered. Once written consent is provided and the ...
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A Randomized Study to Evaluate the Effect of Rapamycin in Improving Cardiac Function in Older Adults with Heart Failure
Rochester, MN
The purpose of this study is to address the unmet need of an effective pharmacologic intervention in patients with Heart Failure with Preserved Ejection Fraction (HFpEF) and leverage the favorable cellular underpinnings of rapamycin to improve multiorgan reserve capacity and physical function with reduction in inflammation and cellular senescence (biological aging).
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A Study to Evaluate the Thoracotomy Implant Technique of the HeartWare HVAD System in Patients with Advanced Heart Failure
Rochester, MN
This is a prospective, multi-center,single arm study that will evaluate the thoracotomy implant technique in up to 120 subjects implanted via thoracotomy with the HeartWare HVAD® System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) protocol and database. All participating centers will be current INTERMACS® sites in good standing and will follow the INTERMACS® protocol and procedures.
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Evaluating a Mobile Health Monitoring Platform for Capturing Patient-centered Outcomes Among Heart Failure Patients
Jacksonville, FL
The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Patients with HF have reduced function capacity and quality of life (QoL) and hence it is imperative to explore interventions that impact endpoints that directly measure how a patient feels or functions on a daily basis. Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms. These technologies are able to capture and integrate data from disparate sources from individual patients reflecting ...
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Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging
Rochester, MN
Congestive heart failure (CHF) affects nearly 5 million Americans and claims more than 300,000 lives annually. A primary pathophysiologic mechanism in this deadly syndrome is an abnormally enhanced sympathetic nervous system that results in profound peripheral vasoconstriction, attenuated cardiovascular reflexes, higher susceptibility to ventricular arrhythmias, and sudden cardiac death. The reduction in mortality and morbidity in CHF by pharmacologic neurohumoral antagonists such as beta-receptor inhibitor and angiotensin II-converting enzyme (ACE) inhibitor has taught us that regulation of the impaired neurohumoral axis is important for improving clinical outcome. In addition, an emerging nonpharmacologic approach, cardiac resynchronization therapy (CRT), has shown promise ...
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A Study to Evaluate the Safety and Tolerability of LCZ696 Followed by a 52-week Study of LCZ696 Compared With Enalapril in Pediatric Patients with Heart Failure
Rochester, MN
This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in pediatric heart failure patients over 52 weeks of treatment.
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A Study to Compare Non-Invasive Venous Waveform Analysis (NIVA) with Total Blood Volume (TBV) in Patients Admitted to the Hospital with Acute Decompensated Heart Failure
Rochester, MN
The primary purpose of this study is to evaluate the correlation between Non-Invasive Venous Waveform Analysis (NIVA) score and Total Blood Volume (TBV) in Heart Failure (HF) patients on admission for decompensation and at discharge after diuresis.
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Dapagliflozin (DAPA) Effects in HFpEF
Rochester, MN
The purpose of this study is to determine whether treatment with Dapagliflozin (DAPA) for 6 months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart failure/preserved ejection fraction (HFpEF) and improve cardiac metabolism.
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Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the WiSE-LV System for Cardiac Re-synchronization Therapy.
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Reducing 30-day Readmissions in Patients With Heart Failure Through Pharmacist Discharge Medication Services
La Crosse, WI
Patients admitted for heart failure that are provided discharge medication services by a pharmacist are less likely to be readmitted within 30 days of primary admission.
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A Study to Establish a Product Surveillance Registry (DTPAS) Apogee (addendum to the Medtronic, Inc. Product Surveillance Registry / Destination Therapy (DT) Post Approval Study (PAS)) Platform Addendum
Jacksonville, FL
The primary purpose of this study is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use.
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Cardiac Rehabilitation in Heart Failure With Mitochondrial Adaptation To High-intensity Interval Training
Rochester, MN
The purpose of this study is to examine PRO-HIIT compared with CON-HIIT on effectiveness for improving locomotor muscle mitochondrial function in heart failure (HF) patients.
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Single-Ascending Dose Study of JK07 in Subjects With HFpEF
Rochester, MN
The purpose of this study is to assess the safety and tolerability profile of JK07, administered intravenously, according to protocol-defined dosing regimen.
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Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
Scottsdale/Phoenix, AZ
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.
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A Study to Evaluate Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin-Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)
Jacksonville, FL
The purpose of this study is to determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.
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A Study of Inorganic Nitrite Delivery to Improve Exercise Capacity in Patients with Heart Failure with a Preserved Ejection Fraction
Rochester, MN
The purpose of this study is to assess the effect of inorganic nitrite on aerobic capacity (peak VO2) after four weeks of giving it to patients who have heart failure with a preserved ejection fraction.
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Cardiac Rehab for Advanced Heart Failure-LVAD Candidates
Rochester, MN
This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD therapy.
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Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
Rochester, MN
Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes associated with the use of this therapy.
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Diastolic Dysfunction Using Artificial Intelligence Applied to a Single Handheld Ultrasound Image
Rochester, MN
The aim of this study is to prospectively validate the novel AI based model in patients undergoing clinically indicated transthoracic echocardiography using a four-chamber view acquired with a hand-held point of care ultrasound.
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Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction
Rochester, MN
A randomized, double-blinded, placebo-controlled crossover study to assess effect of isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn, tri-axial) accelerometry.
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A Study of the Safety and Effectiveness of Home Monitoring of Blood Clotting Factors in Adults with Congenital Heart Disease
Rochester, MN
The purpose of this study is to compare the safety and effectiveness of home monitoring of INR (blood clotting factors) to standard of care clinic monitoring for adults with congenital heart disease.
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Inhaled Sodium Nitrite on Heart Failure with Preserved Ejection Fraction
Rochester, MN
Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study will assess the effects of nebulized inhaled nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred to the catheterization lab.
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A Study to Gather Information to Develop and Validate a Tool for Predicting the Response to Cardiac Resynchronization (CRT) Therapy
Rochester, MN
The purpose of this study is to gather information to develop and validate a predictive tool for predicting the response to CRT therapy.
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A Study of the Incidence and Risk Factors Associated with HeartMate II Pump Thrombosis Events
Rochester, MN
The purpose of this study is to assess how often blood clots form in the FDA-approved HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to clotting within the pump.
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A Dose Ranging Phase IIa Study of 6 Hour Intravenous Dosages of CXL-1427 in Patients Hospitalized With Heart Failure
Jacksonville, FL
A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure.
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MOMENTUM 3 IDE Clinical Study Protocol
Rochester, MN
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
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A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Scottsdale/Phoenix, AZ
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease. The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.
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A Study to Evaluate the Disease Development and Impact of Intravascular Volume Expansion Profiles in Relation to Neuroendocrine and Renal Function in Post-Acute Heart Failure
Rochester, MN
The purpose of this study is to assess intravascular volume heterogeneity in relation to neuroendocrine profiles in patients admitted to hospital with decompensated acute on chronic systolic heart failure with serial assessments post-discharge
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Guiding Evidence Based Therapy Using Biomarker Intensified Treatment
Rochester, MN
The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.
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A Study to Determine the Effects of Cardiac Resynchronization Therapy on Blood Vessel Tissue and Heart Function for Patients with Heart Failure
Rochester, MN
The purpose of this study is to determine the role of blood vessel tissue function in heart failure, and the effect of cardiac resynchronization therapy (CRT) on tissue and heart function.
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Superficial Cervical Plexus Block for Pacemaker Insertion
Jacksonville, FL
The purpose of this study is to investigate clinical outcomes from two current standard of care pain control procedures performed for patients undergoing pacemaker insertion.
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Shockless IMPLant Evaluation in Replacements
Rochester, MN
The purpose of this study is to demonstrate the event rate of the primary outcome, defined as failure of DFT at a single shock at 10 Joules below maximal capacity of the device.
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Diet, Vascular Health and the Gut Microbiome in Heart Failure
Scottsdale/Phoenix, AZ
Heart failure with reduced ejection (HFrEF) is a major health concern. HFrEF is associated with significant endothelial dysfunction (ED). The purpose of this study is to compare the effects of a Western diet (WD) to a high-carbohydrate, high-fiber diet (HCHF) on endothelial function in patients with HFrEF. the study will look at the distribution of intestinal microbe communities after following the diets as well as explore relationships between gut health and ED in patients with HFrEF.
We propose to address this important gap in the literature with a study design that is responsive to needs in the area of healthcare delivery and ...
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Heart Failure in the Community
Rochester, MN
The purpose of this study is to characterize the contribution of isolated diastolic heart failure to heart failure using active surveillance to measure the plasma levels of brain natriuretic peptide (BNP) among persons with heart failure and to define the prognostic value of BNP in all cases of heart failure.
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A Study of Cardiopulmonary Exercise Heart Sound S1
Rochester, MN
The purpose of this study is to evaluate the ability to determine the first heart sound (S1) and its relationship to aerobic capacity.
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Heart Failure (HF) Clinic Biobank
Rochester, MN
The objectives of this study are to collect and store samples and information from participants’ health records for future research about heart failure.
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REDUCE LAP-HF TRIAL II
Rochester, MN
The purpose of this study is to evaluate the clinical efficiency and safety of a non-surgical medical device (the IASD System II) in symptomatic heart failure patients.
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A Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Rochester, MN
Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).
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A Study of Continuous Simultaneous Recording of Skin Sympathetic Nerve Activity and Electrocardiography for Predicting the Sudden Start of Ventricular Arrhythmia Events and Response to Treatment
Rochester, MN
The purpose of this study is to use a noninvasive method of recording together skin sympathetic nerve activity and electrocardiogram (ECG) to assess the sympathetic activity of the heart. The potential use of this is in the prediction of ventricular arrhymia and identifying the response to resynchronization therapy.
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Caregivers of Patients with Heart Failure
Rochester, MN
The purpose of this study is to identify the burden, benefits, or impact of caregiving on the health of the caregiver and patient with heart failure.
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A Study to Evaluate the Effect of the Transient Receptor Potential Vanilloid 4 (TRPV4) Channel Blocker, GSK2798745, on Pulmonary Gas Transfer and Respiration in Patients With Congestive Heart Failure
Rochester, MN
This study is a single centre, randomised, double-blind, sponsor-unblinded, placebo-controlled, 2 by 2 crossover study in adults with heart failure. In blocking the TRPV4 ion channel and reducing pulmonary interstitial fluid, GSK2798745 may improve pulmonary function, respiration, and gas exchange as well as sleep-disordered breathing in patients with heart failure. Therefore, the current study is designed to investigate the effect of repeat administration of GSK2798745 on pulmonary gas exchange and pulmonary function.
A sufficient number of subjects with heart failure will be enrolled so that 12 subjects complete the two study periods and critical assessments. Subjects will be randomised to receive ...
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A Study to Continue to Evaluate the Safety and Clinical Performance of the MOMENTUM 3 Left Ventricle Assist System
Rochester, MN
The purpose of this study is to continue to evaluate the safety and clinical performance of the HeartMate MOMENTUM 3 left ventricle assist system for the treatment of advanced, refractory, left ventricular heart failure following completion of participation in the the MOMENTUM 3 IDE study.
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A Study to Evaluate the Burden of Treatment and Illness in Advanced Heart Failure Patients
Rochester, MN
The primary purpose of this study is to identify which aspects of treatment are most prevalent and burdensome to patients with advanced heart failure.
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A Study to Evaluate the Effect of Motion and Poor Circulation on Various Pulse Oximeter Performances During Heart Failure Stress Tests
Rochester, MN
The purpose of this study is to compare pulse oximetry performances from different manufacturers and with different anatomical sensor locations during stress tests in heart failure patients, evaluating effectiveness against motion and poor circulation.
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A Study to Compare the Rate of Major Cardiovascular Implantable Electronic Device Infections with the Absorbable Antibacterial Envelope and without
Rochester, MN
The purpose of this study is to evaluate the ability of the TYRX Absorbable Antibacterial Envelope to reduce major cardiovascular implantable electronic device infections through 12-months post-procedure following generator replacement, upgrade, revision, or new CRT-D implant.
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A Study of Ultrasound Shear Wave Elastography to Assess Heart Muscle Stiffness for Patients with Diastolic Heart Failure
Rochester, MN
The purpose of this study is to investigate the use of shear wave elastography to assess diastolic heart muscle stiffness for diastolic heart failure patients, and compare the stiffness measurements with the cardiac catheterization (cath lab) results.
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A Study to Evaluate Autologous Bone Marrow Mononuclear Cells Using the CardiAMP™ Cell Therapy in Patients With Post Myocardial Infarction Heart Failure
Scottsdale/Phoenix, AZ
The purpose of this study is to compare treatment with the CardiAMP cell therapy to a sham treatment. A roll-in phase with a maximum of 10 subjects will precede the randomised phase.
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A Study for Sources of Pulmonary Congestion Associated with Heart Failure
Rochester, MN
The purpose of this study is to measure and identify chest fluid volumes associated with heart failure and to determine their impact on lung structure and function, and also assess the effect of body position on shifts in fluid and the effects of this on lung function, mechanics and gas exchange.
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A Study to Understand How Feedback from Breathing Muscles Influence Blood Flow and Blood Pressure during Exercise and if this can Reduce a Response in Heart Failure Patients with Breathing Muscle Training
Rochester, MN
The purpose of this study is to understand how feedback from your breathing muscles influence blood flow and blood pressure during exercise and if we can reduce this response in heart failure patients with breathing muscle training.
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Enhancing the Natriuretic Peptide System in HFpEF
Rochester, MN
The purpose of this study is to look at the differences in how individuals with HFpEF-CKD and HFpEF-EI’s bodies function using Sacubatril/valsartan (Entresto 97/103 mg), which is FDA approved for the management of HFpEF, and MANP which is an investigational drug.
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Heart Failure and Cardiothoracic Transplant Biorepository
Rochester, MN
This study is being done to develop a serum and tissue bank for future research of patients with heart failure, mechanical circulatory support and/or cardiothoracic transplants. This blood/tissue will be used for three principle purposes: (1) laboratory tests which will be available in the future but that are not currently available and which may be of benefit to the patient, (2) review of previous patient laboratory results made necessary by development of a new disease process by the patient, and (3) future unspecified research purposes.
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Resistance Training in HFpEF
Rochester, MN
The objective of this proposal is to determine the effect of resistance exercise training on locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF patients with preserved ejection fraction (HFpEF).
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A Study of Long-Term Outcomes of Cardiac Resynchronization Therapy Recipients with Congestive Heart Failure
Rochester, MN
The purpose of this study is to determine the long-term outcome of cardiac resynchronization therapy (CRT) recipients with congestive heart failure and any indications for CRT at Mayo Clinic.
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Correlation of SOZO BIS Measures With CardioMEMS PA Pressure
Rochester, MN
This study aims to establish the degree to which change in the ratio of ECF to TBW measured using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured using the CardioMEMS HF System (St. Jude Medical).
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A Study to Evaluate Injectafer® as Treatment for Heart Failure with Iron Deficiency
Rochester, MN
The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction.
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Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Patients With Worsening Heart Failure
Rochester, MN
Primary Objectives: - Assess the safety and tolerability of sotagliflozin in hemodynamically stable patients with worsening of heart failure, compared to placebo. - Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable patients with worsening of heart failure, compared to placebo. Secondary Objectives: - Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma erythropoietin levels, in hemodynamically stable patients with worsening of heart failure, compared to placebo. - Explore the effect of sotagliflozin on changes in plasma NT-proBNP levels, in hemodynamically stable patients with worsening of heart failure, compared to placebo.
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Genomic Response Analysis of Heart Failure Therapy in African Americans
No Locations
The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self designated African American subjects with systolic heart failure. They will be followed for up to two ...
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A Study of Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure that has Preserved Ejection Fraction
Rochester, MN; Cannon Falls, MN; La Crosse, WI; Albert Lea, MN; Austin, MN; Red Wing, MN; Mankato, MN
Participants with heart failure with preserved ejection fraction will undergo 12 weeks of cardiac rehabilitation for exercise training (ET) and be randomized to either nebulized sodium nitrite inhalation solution or placebo inhalation solution (normal saline) through the training period. Study drug is administered 3 times daily during daytime hours with one of these doses being immediately prior to onset of ET sessions throughout the 12 week trial. The objective is to determine if the inhaled sodium nitrite improves the clinical responses and tolerability of ET.
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A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.
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Hospital Admission in Heart Failure: Readiness for Discharge and Predicting Future Admissions
Rochester, MN
The purpose of this study is to identify measures of heart rate and heart rate variability responses to changes in nervous system activity, breathing variability, and lung fluid in HF patients as early as possible in the course of their hospital admission and subsequently just prior to discharge, using a simplified approach, in order to determine if these measures can assess readiness for discharge and more accurately predict likelihood for readmission.
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Beta-Blockers and Bone Health
No Locations
The proposed study will directly examine whether bone mineral density (BMD) and bone microstructure are better preserved among HF patients on chronic β-blockers and account for the reports of decreased fracture.
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Gene Polymorphisms in Cardiovascular Health and Disease
Rochester, MN
The purpose of this study is because we are testing the variation in a gene that may influence receptors in your heart, blood vessels and lungs.
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INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Rochester, MN
INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.
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The Ventilatory Response to Activation of the Locomotor Afferents in Normoxic and Hypoxic Conditions
Rochester, MN
The purpose of this study is two-fold. The first purpose is to understand how feedback from your muscles can change ventilation at rest and during exercise in low and high oxygen conditions. The second purpose is to understand how feedback from your muscles can influence muscle fatigue and muscle function in normal and low oxygen conditions. The ventilatory response to exercise and skeletal muscle fatigability in healthy controls and HF patients will advance our understanding of tolerance to exercise in HF patients.
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Inotropes: Intent and Result of Elective Initiation During Heart Failure Hospitalization
Rochester, MN
The purpose of this study is to identify clinical demographics of patients initiated on inotropes during a heart failure admission and observe clinical practice surrounding their use as well as compare whether the perception of treatment duration/outcome of the treating clinicians is different to actual clinical outcomes.
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An After Approval Study of the CardioMEMS Heart Failure System
Scottsdale/Phoenix, AZ
The purpose of the CardioMEMS HF System post approval study is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
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A Study to Evaluate the Effectiveness and Safety of Human Bone Marrow Derived Stem Cells (CEP-41750) for the Treatment of Chronic Heart Failure.
Scottsdale/Phoenix, AZ
The primary objective of this study is to determine whether transendocardial delivery of human bone marrow-derived stem cells (CEP-41750) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.
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Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population
Rochester, MN
We will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system
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Evaluation of Rate Adaptive Pacing on Chronotropic Response in Preserved Ejection Fraction HF
Rochester, MN
RESPOND-HF is a prospective, multi-center, non-significant risk pilot study with cross-over design. The purpose of the study is to investigate if rate adaptive pacing has the potential to provide benefit to HF patients with preserved ejection fraction, referred to as HFpEF patients. Findings from this pilot study may be used to guide subsequent efforts to design and conduct a prospective, randomized, multi-center pivotal trial powered to show improvement in patient outcomes.
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A Study to Examine if People Without HFpEF Display Less Visceral Adipose Tissue (VAT) Compared to Patients with Diagnosed HFpEF
Rochester, MN
The purpose of this study is to examine whether people without HFpEF display less visceral adipose tissue (VAT) compared to patients with diagnosed HFpEF.
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A Study to Evaluate the Utility of Focused Frailty Interventions on Patients with Advanced Heart Failure
Rochester, MN
The purpose of this study is to assess frailty in patients being evaluated in the Congestive Heart Failure Clinic with NYHA class III-IV heart failure and to enroll these patients in cardiac rehabilitation program aimed at improving frailty and functional independence.
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Predictors of Healthcare Resource Utilization in Patients with Heart Failure
Rochester, MN
We will longitudinally (at enrollment and 6 months after) ascertain patients’ end of life preferences, patient activation and health literacy in prospectively enrolled Southeastern Minnesota residents hospitalized with heart failure (HF).
We will define the relationship between HF patients’ end of life preferences and degree of advance care planning and healthcare resource utilization.
We will measure perceived treatment burden in patients hospitalized with heart failure using a novel questionnaire that has been validated in patients with multimorbidity.
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Study to Evaluate the Detection Performance and Safety of an Investigational Wearable Cardioverter Defibrillator (WCD)
Rochester, MN
The purpose of this study is to evaluate the detection performance and safety of an investigational Wearable Cardioverter defibrillator (WCD).
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A Study to Compare Microembolic Signal Detection and Cerebral Vasomotor Reactivity on Transcranial Doppler in Patients with Left Ventricular Assistance Devices
Jacksonville, FL
The purpose of this study is to compare microembolic signal detection (MSD) and cerebral vasomotor reactivity (CVR) on transcranial doppler in patients with left ventricular assistance devices.
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Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
Rochester, MN
To determine if a strategy of early discharge using a novel subcutaneous delivery system for parenteral furosemide can improve clinical outcomes within 30 days of randomization (days alive and outside the hospital) compared to usual care.
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A Study to Assess Respiratory Muscle Training as a Quality Improvement of Perioperative Care in LVAD Patients
Rochester, MN
The objectives of this study are to determine the best method for integration of respiratory muscle training (RMT) into the clinical ventricular assist device (VAD) practice at Mayo, to determine the clinical benefits of using RMT in the VAD population at Mayo Clinic, to gain initial insight on means by which RMT can impact clinical outcomes in the VAD population, and to create an algorithm for integration of perioperative RMT in the VAD and other distinct populations at Mayo Clinic.
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A Study Using Spinal Stimulation During Exercise in Patients with Heart Failure
Rochester, MN
The purpose of this study is to determine if epidural spinal cord stimulation can affect blood pressure control and blood vessel resistance during exercise in heart failure patients by intercepting messages of muscle fatigue and shortness of breath.
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Barriers to Cardiac Rehabilitation
Rochester, MN
The purpose of this study is to assess barriers to completion of cardiac rehabilitation program and to identify potential ways to improve cardiac rehabilitation completion.
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A Study for the Continued Access of the Micra Transcatheter Pacing System
Rochester, MN
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
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Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure
Rochester, MN
The primary objective of this study is to test the hypothesis that high-dose spironolactone will lead to greater proportional reduction in NT-proBNP levels from randomization to 96 hours over standard of care.
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Ultrasound-based Technology (similar to standard clinical echocardiography) for Measuring the Stiffness of Heart Muscle and Peripheral Arteries
Rochester, MN
The purpose of this study is for evaluating an ultrasound-based technology (similar to standard clinical echocardiography) for measuring the stiffness of your heart muscle and your peripheral arteries. This type of information may prove to be clinically important.
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Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure
La Crosse, WI; Eau Claire, WI; Jacksonville, FL
This study evaluates the effectiveness of remote tele-monitoring and health coaching in helping to reduce hospitalizations in heart failure patients. Half of participants will receive tele-monitoring and health coaching, while the other half will receive standard health care provided by their chosen provider.
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A Study to Evaluate Electrocardiogram Artificial Intelligence-Guided Screening for Low Ejection Fraction (EAGLE)
Rochester, MN
The purpose of this study is to prospectively evaluate a newly-developed screening tool for ALVSD.
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Ventricular Remodeling and Heart Failure after Myocardial Infarction: A Community Study
Rochester, MN
To comprehensively characterize Left Ventricular (LV) remodeling after Myocardial Infarction (MI) in the community, study the association between patterns of remodeling and biological pathways and examine the association between the predictors of remodeling and heart failure after Myocardial Infarction.
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Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
Rochester, MN
The purpose of this research is to find out if an aggressive intervention to lose weight, will improve symptoms in patients with obesity-related cardiomyopathy, which is also known as the obese phenotype of heart failure with preserved ejection fraction (HFpEF).
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High Sensitive Multichannel Non-Invasive Blood Pressure Monitor
No Locations
The objective of this study is to obtain preliminary data to evaluate the accuracy of non-invasive blood pressure measurement in patients supported by continuous-flow left ventricular assist device (LVAD) using non-invasive supra-systolic methods in highly sensitive experimental blood pressure monitor.
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Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PHHFpEF)
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects.
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A Study to Evaluate the Effectiveness and Safety of G10 in Subjects with Transthyretin Amyloid Cardiomyopathy
Rochester, MN
The purpose of this study is to evaluate AG10 800 mg compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
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Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients with Pulmonary Hypertension
Jacksonville, FL
The purposed of this study are to investigate whether structured exercise training improves cardiac and pulmonary haemodynamic function, exercise capacity, and short-term clinical outcomes in heart failure (HF) patients with Pulmonary Hypertension (PH), and to develop a multivariable exercise pulmonary gas exchange ‘score’ that accurately differentiates HF patients with pre- and post-capillary PH (CpcPH) from HF patients with isolated post-capillary PH (IpcPH).
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Chronic Obstructive Pulmonary Disease (COPD) in Patients Hospitalized for Acute Decompensated Heart Failure
Rochester, MN
The presence of chronic obstructive pulmonary disease (COPD) would confer increased in-hospital mortality and length of hospital stay in patients with acute decompensated heart failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute decompensated heart failure and (2) the association between COPD and in-hospital mortality or length of stay in this cohort.
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A Study to Evaluate Noninvasive Ultrasound Elastography of Kidney and Lung in Assessment of Volume Status in ICU Patients
Rochester, MN
The primary purpose of this study is to assess the feasibility of performing lung and kidney and lung ultrasound elastography among patients with critical illness from different etiologies that could be associated with volume overload.
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Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli
Rochester, MN
Patients with a patent foramen ovale in the setting of endocardially placed cardiac implantable electronic devices such as pacemakers, defibrillators, or resynchronization therapies are likely at higher risk for paradoxical embolic events from device lead thrombus. The investigators are conducting this study to determine if the anticoagulant medication Apixaban is more effective at reducing MRI detected brain lesions compared to placebo.
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An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered via Transendocardial Catheter-based Injections to Subjects with Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)
Scottsdale/Phoenix, AZ
This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.
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Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of 134 days of daily dosing of HU6, to ealuate the effectiveness of HU6 on weight reduction, and to evaluate the effect of HU6 treatment on exercise capacity.
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A Study of the Impact of MayoExpertAdvisor on Provider Adherence to Guideline Recommendations
Rochester, MN
The purpose of this study is to evaluate the effectiveness of MayoExpertAdvisor, a knowledge delivery tool, to improve provider adherence to guidelines of best practice for patients with hyperlipidemia, atrial fibrillation and heart failure.
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Rivet PVS Therapy in Group 2C
Rochester, MN
The purpose of this study is to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension.
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A Study of Allopurinol to Relieve Symptoms in Patients with Heart Failure and High Uric Acid Levels
Albert Lea, MN; Rochester, MN
The purpose of this study is to determine if allopurinol is effective in relieving symptoms for patients who have heart failure and high blood uric acid levels.
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A Study of the Safety and Effectiveness of NEOD001 for Treating Previously Treated Patients with Persistent Cardiac Dysfunction Related to Light Chain Amyloidosis
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness and safety of NEOD001 administered intravenously in adults with light chain amyloidosis who have had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.
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Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial
Rochester, MN
The enormous and rapidly growing burden of Heart Failure with Preserved Ejection Fraction (HFpEF) has led to a need to understand the pathogenesis and treatment options for this morbid disease. Recent research from the investigator's group and others have shown that pulmonary hypertension (PH) is highly prevalent in HFpEF, and right ventricular (RV) dysfunction is present in both early and advanced stages of HFpEF.
These abnormalities in the RV and pulmonary vasculature are coupled with limitations in pulmonary vasodilation during exercise. There are no therapies directly targeted at the pulmonary vasculature that have been clearly shown to be effective ...
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Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)
Jacksonville, FL
This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects will take the initial dose of study drug at the study site on the day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.
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Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)
Jacksonville, FL
This is an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil becomes commercially available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.
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A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Effectiveness is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).
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A Study to Evaluate the Accuracy of Cardiac Acoustic Biomarkers by the Wearable Cardioverter Defibrillator
Rochester, MN
The purpose of this study is to evaluate the data accuracy of the cardiac acoustic biomarkers (CABs) recorded the FDA-approved LifeVest® Wearable Cardioverter Defibrillator (WCD). To show accuracy, these data will be compared with CABs data simultaneously recorded by the AUDICOR® AM device, a FDA cleared, acoustic cardiography recorder.
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A Study of Levosimendan in Pulmonary Hypertension (PH) with Heart Failure (HF) and Preserved Left Ventricular Ejection Fraction (pEF) Patients
Rochester, MN
The purpose of this study is to evaluate for safety and effectiveness weekly, open-label doses of levosimendan over extended use in patients with pulmonary hypertension with heart failure and preserved left ventricular ejection fraction (PH-HFpEF).
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Accelerated Stem Cell Senescence in Heart Failure
Rochester, MN
The purpose of this study is to study circulating progenitor cells in human subjects with heart failure and before and after LVAD therapy.
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A Study of Biomarkers for Human Heart Failure
Rochester, MN
The purpose of this study is to attempt to establish the various ranges of proteins that can be assayed from the plasma and urine of patients with all classes of heart failure and MI (myocardial infarction).
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Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure
Rochester, MN
This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) <0.40, and secondary pulmonary hypertension (PH). The purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil compared to placebo on the subjects' functional capacity / quality of life.
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A Clinical Trial to Evaluate the HeartWare Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
Rochester, MN
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy). Subjects will be randomized to HeartWare HVAD or ...
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A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is test the effectiveness and safety of NNC6019-0001 to determine if it can reduce the symptoms of a heart disease due to TTR (Transthyretin ) amyloidosis, such as heart failure.
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CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction - Pilot Study
Rochester, MN
The primary endpoint is to assess the safety and tolerability of CD-NP with the incidence of symptomatic hypotension being one of the key safety variables.
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An Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With Heart Failure (HF)
Rochester, MN
The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) pediatric patients receiving open-label sacubitril/valsartan.
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Screening for Pregnancy Related Heart Failure in Nigeria
Jacksonville, FL; Rochester, MN
The purpose of this studyis to determine the effectiveness of an AI-enabled ECG to detect cardiomyopathy and its impact on clinical outcomes in a predominantly Black obstetric population in Nigeria
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Cardiovascular Disease Specimen Repository
Rochester, MN
The purpose of the study is collect specimens for future studies to identify markers circulating in the blood that are associated with the development of further complications of heart disease.
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Safety and Efficacy of ANX-042 in Human Cardiorenal Syndrome
Rochester, MN
The purpose of this study is to look at kidney function and hormonal function in patients with a history of heart failure and kidney dysfunction, and to see how the use of a new drug, ANX-042, affects those functions.
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Skin Sympathetic Nerve Activity in Patients with Arrhythmia or Heart Failure
Rochester, MN
The purpose of this study is to investigate skin sympathetic nerve activity (SKNA) in correlation with cardiac arrhythmias and/or heart failure.
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A Study of the Effects of Decreasing the Lasix Dose on the Cardiorenal System
Rochester, MN
The purpose of this study is to define the effects of decreasing the furosemide (lasix) dose on heart, kidney and biochemical balance, in people with compensated heart failure and kidney dysfunction and also in people with compensated heart failure without kidney dysfunction.
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Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI) in Patients Hospitalized for Volume Overload Decompensated Chronic Heart Failure
Rochester, MN
The purpose of this study is to evaluate the baseline presence of plasma levels of biomarkers of renal injury and changes in these biomarkers during the course of in-hospital intravenous diuretic therapy can predict when threshold values that would indicate a clinically significant change in renal function that would warrant a change in diuretic therapy to occur.
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Get Going: Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults
La Crosse, WI; Rochester, MN
A multicenter prospective randomized clinical trial testing the hypothesis that a patient-centered actigraphy intervention will result in increased physical activity for frail older adults increase during the critical first 30 days after a cardiovascular hospitalization.
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A Study to Identify Late-Occurring Complications in Childhood Cancer Survivors
Rochester, MN
The purpose of this trial is to identify cancer survivors who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.
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A Study to Evaluate Cardiotoxicity in Total Hip and Knee Arthroplasty
Rochester, MN
The purposes of this study are to determine: the risk of cardiomyopathy and heart failure, and cardiac structure and function in patients with THA and TKA. This study will also determine the association between serum and/or synovial fluid metal ion levels with cardiac structure and function in 100 prospectively-recruited THA and TJA patients.
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Study to Evaluate the Safety and Effectiveness of IW-1973 Dosing over 12 Weeks in Patients with Congestive Heart Failure with Preserved Ejection Fraction
Scottsdale/Phoenix, AZ
The purpose of this 12 week study is to assess the safety of oral IW-1973 when administered to patients with heart failure with preserved ejection fraction (HFpEF) and its effect on peak exercise capacity, both in all patients and in patients without permanent or persistent atrial fibrillation
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A Study of Oxygen Cost of Exercise in Patients with and without Heart Failure
Rochester, MN
This study is being done to: (1) develop a simple tool to assess breathing muscle performance; (2) measure the oxygen cost of breathing during exercise; (3) measure the respiratory muscle blood flow requirements of hyperpnea during exercise; and (4) to quantify the energy cost of exercise in relation to disease severity.
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Use of Cardiac Magnetic Resonance Imaging (cMRI) and Echocardiogram to Diagnose Constrictive Pericarditis and Restrictive Cardiomyopathy
Rochester, MN
The purpose of this study is to learn whether Cardiac Magnetic Resonance Imaging (cMRI) and/or echocardiogram is useful to diagnose patients with unique heart conditions. This research study focuses on evaluating the use of cMRI or echocardiogram as a novel, non-invasive method for evaluating specific heart conditions.
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Pericardial Resection to Treat Heart Failure
Rochester, MN
The researchers are doing this study to find out whether there will be less increase in cardiac filling pressure after the surgeon opens the pericardium (the membrane around the heart) than when the pericardium is intact. The researchers want to see whether opening the pericardium is an effective way to reduce the blood filling pressures in the heart.
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A Study to Evaluate the Prevalence of Transthyretin Cardiac Amyloidosis in Heart Failure Patients with Preserved Ejection Fraction in Southeastern Minnesota
Rochester, MN
The primary objective of this study is to determine the prevalence of transthyretin cardiac amyloidosis (TTR-CA) in a community-based cohort of consecutive heart failure with preserved ejection fraction (HFpEF) patients with increased LV wall thickness using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT). As a secondary (exploratory) objective, we seek to establish and validate novel biomarker assays to screen for TTR-CA using blood and urine samples collected from study participants.
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Metabolic Mapping and Cardiac Resynchronization
Rochester, MN
The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB).
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Preventing Anthracycline Cardiovascular Toxicity with Statins (PREVENT)
Rochester, MN
The purpose of this research study is to see if Atorvastatin(Lipitor) 40 mg by mouth daily decreases the chance of developing heart problems in women who are receiving anthracycline-based chemotherapy for breast cancer.
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A Noninvasive Monitor for the Detection of Preclinical Heart Failure in Children with Congenital or Acquired Heart Disease
Rochester, MN
The primary objective of this study is to determine whether a Mayo-developed, highly miniaturized physiologic monitoring instrument can provide early detection of heart failure (HF) in children with congenital or acquired heart disease at risk for or with evidence of heart failure (HF).
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Characterizing HIV-related Diastolic Dysfunction
Rochester, MN
The purpose of this study is to better understand how the heart’s health and function is affected by HIV infection and use of active antiretroviral therapy.
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Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
Rochester, MN
The purpose of this study is to look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week.
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A Study to Evaluate Exercise Capacity and Positive Airway Pressure Impact on Sleep Apnea in Heart Failure
Rochester, MN
The purpose of this study is to determine the prevalence of Obstructive Sleep Apnea (OSA) in HFpEF, and its clinical and hemodynamic correlates, and to determine the impact of intervention with CPAP therapy on exercise capacity and quality of life in HFpEF patients with OSA.
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Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
Rochester, MN
The purpose of this study is to evaluate comparisons between a hybrid program of center-based CR which incorporates mHealth remote case management technology (CON+) to a traditional center-based program alone (CON) as well as comparisons between home-based mHealth remote case management alone (HOM+) to a traditional center-based program (CON).
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A Study of the Effect of Dapagliflozin on Symptoms and Biomarkers in Diabetes Patients with Heart Failure
Rochester, MN
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients who have type 2 diabetes and chronic heart failure with reduced systolic function.
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Dapagliflozin in Type 2 Diabetes or Pre-diabetes, and PRESERVED Ejection Fraction Heart Failure
Rochester, MN
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure, disease specific biomarkers, symptoms, health status and quality of life in patients with type 2 diabetes or prediabetes and chronic heart failure with preserved systolic function.
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A Study to Reduce Cardiomyopathy in Breast Cancer Patients Being Treated With Trastuzumab
Rochester, MN
The purpose of this study is to evaluate different strategies of cardiovascular therapy with carvedilol aiming to reduce the incidence of heart function declines and heart failure in at-risk breast cancer patients while on trastuzumab therapy.
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Hypertrophic Cardiomyopathy Candidate Gene Homologs in Human and Rhesus Macaque Sudden Cardiac Death Victims
Scottsdale/Phoenix, AZ
The aim of this study is to identify genes shared between humans and rhesus macaque primates who have been diagnosed with hypertrophic cardiomyopathy and have died suddenly.
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A Study to Evaluate Sacubitril-Valsartan for Left Ventricular Reverse Remodeling in Adults with Congenital Heart Abnormality
Rochester, MN
The purpose of this study is to determine the optimal medical therapy to improve left ventricular (LV) function. Improvement in LV function has the potential to reduce the burden of heart failure and improve clinical outcomes in the Tetralogy of Fallot (TOF) population.
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A Study to Investigate Outcomes and Management Effectiveness of Cardiogenic Shock II Patients
Rochester, MN
The purpose of this study is to develop a registry of patients with clinical cardiogenic shock (CS) in order to allow better definition of several key issues regarding cardiogenic shock.
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Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
Rochester, MN
The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.
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Virtual World-based Cardiac Rehabilitation Program to Encourage Healthy Lifestyle Choices Among Cardiac Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The aim of this project is to assess the feasibility and utility of a virtual world-based cardiac rehabilitation (CR) program as an extension of a face-to-face conventional CR program (Destination Rehab).
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Autologous Induced Pluripotent Stem Cells of Cardiac Lineage Delivered Into Heart Muscle for Congenital Heart Disease
Rochester, MN
The purpose of this study to test the feasibility and safety for autologous (from your own body) skin cells that are manufactured into stem cells of cardiac lineage to be delivered into the heart muscle to determine if those stem cells will strengthen the heart muscle and can be used as an additional treatment for the management of congenital heart disease.
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A Study of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea to Prevent Cardiovascular Disease
Rochester, MN
Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. This can occur many times during sleep and is known to cause sleepiness and poor concentration during the day. Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure ...
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A Study to Evaluate Brain Natriuretic Peptides for the Avoidance of Treatment-Related Heart Failure in Breast Cancer Survivors
Rochester, MN
The purpose of this study is to determine if Brain Natriuretic Peptide (NT-pro-BNP) values increase over time in breast cancer survivors and correlate with cardiac dysfunction. This study will define the average NT-pro-B-natriuretic peptide values in female breast cancer patients 1, 2, 3, 4, and 5 years out from anthracycline-based chemotherapy.
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A Study to Evaluate Heart Failure Biomarker to Predict Cardiomyopathy After Acute Radiation
Jacksonville, FL
The purpose of this study are to evaluate whether serum sST2 levels increase after RT compared to troponin (as a control), and to correlate serum sST2 and troponin levels at completion of RT with cardiac radiation dosimetry.
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Treating Breast Cancer Patients Undergoing Trastuzumab Treatment with Carvedilol to Reduce Incidence of Heart Failure
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate different strategies of cardiovascular therapy with Carvedilol, aiming to reduce the incidence of left ventricular ejection fraction (LVEF) decline and heart failure (HF) in patients undergoing curative intent Trastuzumab for breast cancer.
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Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation
Rochester, MN
The purpose of this study is to evaluate the impact of interventions on important CV biomarkers to provide valuable information on the mechanism linking depression and anxiety to cardiac prognosis resulting in improved quality of life and diagnosis.
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Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors
Rochester, MN
This randomized phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn't get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.
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Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study
Rochester, MN
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).
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An Evaluation of the MitraClip System for treatment of Mitral Regurgitation in Heart Failure Patients
Scottsdale/Phoenix, AZ
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart ...
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TRPC6 to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure (Prospective Study)
Jacksonville, FL
The purpose of this study is to characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients.
Breast cancer patients are more than three times at risk for developing congestive heart failure (CHF), compared with patients who did not have cancer. The increased risk of HF is observed as early as one year from diagnosis of cancer and overall, 7% of patients develop CHF (median follow-up 8.5 years)
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COVID-19 (Coronavirus) Pandemic on Health and Healthcare
Rochester, MN
The purpose of this study is to identify correlates of healthcare-seeking behavior in patients with ACS and CHF and its association with psychosocial and health outcomes.
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Remote Patient Monitoring (RPM) on Emergency Room Visits, Hospitalizations, Hospital Contacts, and Patient Quality of Life
Jacksonville, FL
Hypothesis: We hypothesize that patients from the Family Medicine Department at Mayo Clinic Florida who participate in RPM will have significantly reduced emergency room visits, hospitalizations, and hospital contacts.
Aims, purpose, or objectives: In this study, we will compare the RPM group to a control group that does not receive RPM. The primary objective is to determine if there are significant group differences in emergency room visits, hospitalizations, outpatient primary care visits, outpatient specialty care visits, and hospital contacts (inbound patient portal messages and phone calls). The secondary objective is to determine if there are ...
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COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications
Rochester, MN
The purpose of this study is to determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19.
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Stress Echo 2030
Rochester, MN
This study (SE2030) will establish a platform of data to build the perfect stress echo test, suitable for all patients, anywhere, anytime, also quantitative and operator independent.
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A Study to Evaluate the Effectiveness and Safety of Remdesivir to Treat Coronavirus Disease 2019 in an Outpatient Setting
Rochester, MN
The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.