Clinical Trials

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.

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symptomatic heart failure (HF) translate to patients with left ventricular assist devices (LVAD) or if they will be superseded by LVAD-specific themes.

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.

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.

This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. ...

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.

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 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 wave, R ...

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.

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.

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.

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.

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 ...

The purpose of this study is to evaluate the safety and effectiveness of the WiSE-LV System for Cardiac Re-synchronization Therapy.

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 ...

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.

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.

The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF). 

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.

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.

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.

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.

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.

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.   

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).

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.

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.

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.

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.

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 ...

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.

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.

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:

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

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.

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.

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, ...

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.

This study will compare two different methods to pace the heart to treat heart failure including:

1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT).
2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area ...

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

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. 

The purpose of this study is to assess the real-world effectiveness and implementation process for allocation of advanced therapies for heart failure (HF), heart transplants and ventricular assist devices, in randomized controlled trial in which participants will be randomized at the group level.

Allocation of advanced therapies for HF is subjective and often biased. We have developed a multi-component standardized protocol (SOCIAL HF) that is designed to achieve racial/ethnic and gender equity in the allocation process by using evidence-based tools to reduce bias, improve objectivity, and improve group function.

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.

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.

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.

The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.

The purpose of this research is to see if having community paramedic (CP) visit patients at home to manage their heart failure help them stay out of the hospital and improve their overall health compared to standard care. We want to find out if their approach is better for patients in terms of their quality of life, hospital stays, emergency visits, and cost. We are also looking to see how happy patients and doctors are with this method and if it’s a practical and sustainable option for the future.

This study is being done to evaluate correlations between echocardiographic Doppler parameters and invasively-measured hemodynamics both at rest and during exercise in a broad cohort of patients referred for cardiac catheterization.

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. 

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 ...

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).

The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.

The purpose of this research is to see if having community paramedic (CP) visit patients at home to manage their heart failure help them stay out of the hospital and improve their overall health compared to standard care. We want to find out if their approach is better for patients in terms of their quality of life, hospital stays, emergency visits, and cost. We are also looking to see how happy patients and doctors are with this method and if it’s a practical and sustainable option for the future.

This study is being done to evaluate correlations between echocardiographic Doppler parameters and invasively-measured hemodynamics both at rest and during exercise in a broad cohort of patients referred for cardiac catheterization.

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).

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.

The primary purpose of this study is to identify which aspects of treatment are most prevalent and burdensome to patients with advanced heart failure.

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 ...

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.

The purpose of this study is to conduct a 6-month longitudinal study of 30 patient/care partner dyads who had an LVAD implanted within the last 6 months. We will comprehensively characterize LVAD self-care trajectories. Our team comprises investigators with experience in heart failure, LVAD patients and care partners, self-management, longitudinal data analysis, and HRQoL.

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.

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.

The objectives of this study are to collect and store samples and information from participants’ health records for future research about heart failure.

Patients awaiting heart transplantation on temporary mechanical support often experience pain and anxiety, and their pre-transplant hospital course is often prolonged. We intend to investigate whether an immersive Virtual Reality headset can improve patients pain and anxiety while awaiting cardiac transplantation using specific patient surveys to assess pain, anxiety, and resilience. 

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.

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 ...

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.

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.

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.

The purpose of this study is to gather information to develop and validate a predictive tool for predicting the response to CRT therapy.

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.

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.

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.

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

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.

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.

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. 

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.

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.

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.

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.

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.

The purpose of this study is to determine the innate immune, cell death and oxidative stress changes in the myocardium, and aorta of patients with heart failure compared to patients with normal hearts.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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.

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).

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).

The purpose of this study is to demonstrate the safety and effectiveness of the VDI UHF-ECG System in the diagnosis of VED when compared to the 12-lead ECG in patients with bradycardia and heart failure indicated for pacemaker implantation.

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.

The purpose of this study is to study circulating progenitor cells in human subjects with heart failure and before and after LVAD therapy.

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.

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 ...

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.

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.
 

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.

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.

This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.

The purpose of this study is to investigate skin sympathetic nerve activity (SKNA) in correlation with cardiac arrhythmias and/or heart failure.

The purpose of this study is to evaluate the efficacy of CS Reducer implantation in patients with HFpEF and CMD on left ventricular filling pressures, specifically invasive measurement of PAWP during standardized exercise.

This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.

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.

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.

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.

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.

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).

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 ...

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.

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.

The purpose of this study is to identify altered biological pathways regulating cardiac structure and function in patients with Heart Failure with Preserved Ejection Fraction (HFpEF).

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.

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.

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

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.

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.

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.

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.

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.

The purpose of this study is to internally validate low-field Ex-CMR as a noninvasive tool for diagnosing, phenotyping, and risk stratifying HFpEF in patients with exertional dyspnea.

To evaluate the effect of CS reducer implantation in patients with HFPEF and CMD on myocardial ischemia, measured by stress myocardial perfusion using cardiovascular magnetic resonance (CMR)

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).

This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.

In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat and empagliflozin tablets, and the other ...

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).

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).

The purpose of this study is to demonstrate acute effectiveness and safety of minimally-invasive pericardiotomy in patients with Heart Failure (HFpEF).

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.

The purpose of this study is to establish both a heart failure (HF) registry and a heart failure with preserved ejection fraction (HFpEF) cohort with deep phenotyping and a biorepository to facilitate mechanistic studies and unbiased discovery approaches to HFpEF.

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.

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.

The purpose of this study is to identify barriers to engaging in physical activity for patients who have heart failure with a preserved ejection fraction, for the design of exercise training programs that these patients are more likely to follow, to improve clinical outcomes and quality of life.

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

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.

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.

A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure.

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.

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.

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.

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.

The purpose of this study is to examine whether people without HFpEF display less visceral adipose tissue (VAT) compared to patients with diagnosed HFpEF.

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.

The purpose of this study is to evaluate the detection performance and safety of an investigational Wearable Cardioverter defibrillator (WCD). 

The purpose of thist study is to find a cost effective CV surveillance of cancer survivors over long periods of time to prevent the risk of progression of HF and related morbidity and mortality. Mobile device-based AI-ECG can reliably detect cardiac dysfunction in lymphoma and sarcoma survivors  and smart watch based surveillance for cardiotoxicity is feasible and reliable.

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.

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).

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. 

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.

The purpose of this study is to prospectively evaluate a newly-developed screening tool for ALVSD.

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

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).

The purpose of this study is to provide continued access to TNX-103 and to assess long-term safety of TNX-103 in patients with PH-HFpEF.

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.

The purpose of this study is to assess the long-term safety and efficacy of i.v. NNC6019-0001 Q4W in participants with hereditary ATTR or wild-type ATTR cardiomyopathy. 

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).

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).

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.

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.

The purpose of this study is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD). 

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.

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 ...

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.

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.

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.

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).

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 ...

This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).

The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.

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.

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.

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.

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

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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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.  

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) 

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 ...

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

We hypothesize that (1) Patients with significant left atrial pressure (LAP) reduction during transcatheter mitral valve repair (TMVR) have lower cardiac output, more advanced diastolic dysfunction, increased left atrial stiffness, abnormal pulmonary vascular function and higher arterial afterload compared to TMVR patients without a significant LAP reduction. (2) TMVR and associated reduction in mitral regurgitation and LAP results in relief of pulmonary vascular congestion, and improvement in pulmonary vascular and right ventricular function.

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.

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 ...

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.

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.

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.