Clinical Trials

The purpose of this study is to evaluate the safety of oral daily dosing of tafamidis meglumine for patients who have either transthyretin genetic variations or wild-type transthyretin, resulting in amyloid disease of the heart muscle.

The purpose of this study is to derive and characterize patient-specific disease models for sudden death-predisposing heritable channelopathies and cardiomyopathies using iPS-cell technology.  It is hoped that the molecular, cellular, and electrophysiological phenotypes of these in-vitro disease models will further elucidate the pathophysiologic mechanisms underlying these sudden death-associated conditions.

The purpose of this study is to evaluate the long-term safety of tafamidis meglumine for treating patients who have either the genetic variants or wild-type transthyretin, resulting in amyloid heart muscle disease.

The purpose of this study is to evaluate the impact of bromocriptine on myocardial recovery and clinical outcomes in women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum.  Given that bromocriptine prevents breastfeeding, women with peripartum cardiomyopathy will be excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.

The primary aim of this study is to measure cardiac troponin (cTn) values with high sensitivity assays in patients with acute peripartum cardiomyopathy (PPCM) in order to determine whether specific fragments exist in these patients. We will also determine whether cTn fragment profile correlates with left ventricular recovery. Finally, we aim to establish a Bio bank in order to facilitate further investigations.

The purpose of this study is to identify hereditary causes of cardiomyopathy.

The purpose of this study is to describe if and how men and women interpret Kansas City Cardiomyopathy Questionnaire (KCCQ) questions differently using qualitative interviews.

This study will investigate the efficacy, safety, and tolerability of an oral dose of 20 mg or 80 mg tafamidis meglumine soft gel capsules in comparison to placebo and given once daily, in addition to standard of care, for 30 months in subjects diagnosed with transthyretin cardiomyopathy (familial and wild-type). The study is designed to assess the potential for benefit from treatment with tafamidis relative to placebo based on all-cause mortality and frequency of cardiovascular-related hospitalizations.

Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.

The purpose of this study is to assess patients with hypertrophic cardiomyopathy (HCM) undergoing first time sternotomy for septal myectomy without known coronary artery disease (CAD).  
 

To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral response to acute sodium loading in subjects with preclinical Diastolic dysfunction (PDD) and renal (kidney) dysfunction

The purpose of this study is to produce and characterize patient-specific cardiac tissue for cardiomyopathy using reprogrammed cell technology. 

The purpose of this study is to use a survey to collect updated information on the clinical status of patients who have hypertrophic cardiomyopathy and are part of the ongoing database at Mayo Clinic.

The purpose of this study is to evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (oHCM [also known as HOCM]) who are eligible for SRT based on American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) and/or European Society of Cardiology (ESC) guidelines (i.e., guideline).

The purpose of this study is to establish safety and preliminary effectiveness of treatment with MYK-491 in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants .

The purpose of this study is to assess the long-term safety and tolerability of mavacamten in participants with hypertrophic cardiomyopathy (HCM) previously enrolled in 1 of 2 placebo-controlled trials: MAVERICK-HCM(MYK-461-006) or EXPLORER-HCM (MYK-461-005).

Previous work has shown that high sensitivity troponin levels are associated with degree of septal hypertrophy in hypertrophic cardiomyopathy. To further evaluate for the mechanisms of this association, we plan to reavaluate the septal pathology from myectomies in patients with HCM. Our hypothesis is that high sensitivity troponin (hs-TnT) and other biomarkers including NT-pro BNP will correlate with septal pathology in hypertrophic cardiomyopathy (HCM).

This is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of mavacamten doses titrated to achieve 1 of 2 target drug concentrations.

The purpose of this study is to describe the changes in cardiac Magnetic Resonance Elastography stiffness in Hypertrophic cardiomyopathy patients pre- and post-myectomy.

The purpose of this study is to

The primary objective of this study is to evaluate the long-term safety and tolerability of AG10 administered to adult patients with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) in patients who have completed the study AG10-201.

The purpose of this study is to

• Establish the long term functional capacity of patients with hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

• Establish patients who do not improve symptomatically on long term follow up

• In patients, who do not have long term symptomatic improvement, ascertain predictors of poor outcomes.

The purpose of this study is to establish initial safety, tolerability, drug/body interactions and biological activity of MYK-461 in people with an enlarged heart, or disease free controls.

This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.

Exercise testing is routinely utilized in the evaluation of patient’s with hypertrophic cardiomyopathy to assess exercise capacity and also to evaluate the presence and severity of obstruction with an echocardiogram. Identifying significant obstruction is important in order to determine who could gain benefit from more invasive therapies like surgery.

There are several different exercise protocols available but it is not known which is the best method to assess the presence and severity of obstruction in hypertrophic cardiomyopathy. The purpose of this study is to determine which exercise protocol (supine bike or exercise treadmill) is better in these regards.

The purpose of this study is to improve heart transplantation and clinical outcomes for transplant patients. The study will enroll individuals who are scheduled for heart surgery where samples from their heart will be collected as part of the normal surgical procedure.

The primary purpose of this study is to assess the long-term safety and tolerability of mavacamten in participants with Hypertrophic Cardiomyopathy (HCM) previously enrolled in 1 of 2 placebo-controlled trials: MAVERICK-HCM for Non-obstructive (nHCM) and EXPLORER-HCM for Obstructive (oHCM).

The purpose of this study is to describe the clinical impact of cardiac rehabilitation in patients who have undergone myectomy for hypertrophic cardiomyopathy.  Compare the clinical outcomes of patients who have attended cardiac rehab with those who have not attended after myectomy for hypertrophic cardiomyopathy. 

This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).

The purpose of this study is:

• To ascertain the prevalence of major adverse cardiac events during pregnancy in patients with history of surgically corrected hypertrophic cardiomyopathy
• To determine the major adverse cardiac events (mortality, arrhythmias, hear failure, endocarditis, pulmonary embolism, myocardial infarction etc) in pregnant women after surgical correction of hypertrophic cardiomyopathy
   

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 determine prevalence of sleep apnea in patients with hypertrophic cardiomyopathy and assess cardiovascular risk markers.

The purpose of this study is see if a new ultrasound-based technique similar to standard clinical echocardiography, called Shear Wave Elastography, can provide reliable early detection of heart muscle damage caused by chemotherapy.

The purpose of this study is to use magnetic resonance elastography to assess heart muscle stiffness in patients with hypertrophic cardiomyopathy compared to normal subjects.

In this study, we attempt to evaluate the LV and RV myocardial mechanical properties   in patients with myocarditis during the acute and convalescent phases.

The purpose of this study is to:

1. Determine the structural accuracy of virtual three dimensional models of heart in patients with hypertrophic cardiomyopathy (HCM).

2. To explore the utility of virtual three dimensional modeling of heart in pre-operative planning of myectomy in patients with hypertrophic cardiomyopathy (HCM).

The purpose of this study is to evaluate the effectiveness and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction.

The purpose of this study is to improve the cardiovascular care of adult cancer survivors by contributing much-needed evidence regarding optimal surveillance and treatment recommendations. This application’s objective is to obtain the data necessary to plan an adequately powered randomized clinical trial (RCT) across a nation-wide network that will define prospectively the clinical and economic efficacy of a screening program that uses AI-ECG and/or NT-pro-BNP in an at-risk adult cancer survivor population.

This study will evaluate the effect of GS-6615 on exercise capacity, quality of life, and safety and tolerability of GS-6615 in participants with symptomatic hypertrophic cardiomyopathy (HCM).

This study is aimed to describe the physiology that changes after operation for apical hypertrophic cardiomyopathy to explain symptom relief.

The purpose of this study is to evaluate the safety, tolerability, effectiveness, biological activity, and drug/body interactions of MYK-461 in adult patients who have symptomatic enlargement of the heart and obstruction of left ventricle outflow.

The purpose of this study is to use data mining methods to identify demographic, clinical, and new CMR, genetic and biomarker variables to then develop a predictive risk assessment model to score a patient's combination of factors for HCM, and establish the evidence base to later enable clinical trial design to reduce the morbidity and mortality of HCM in a cost-effective manner.

Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and prognostic importance given its known association with sudden cardiac death. However, data regarding comparison of imaging modalities for this key measurement is lacking. This study seeks to compare assessment of maximum wall thickness between clinically indicated echocardiography (with and without contrast) and clinically indicated cardiac magnetic resonance imaging.

The purpose of this study is to determine long term vital status, symptoms, and need for repeat procedure after alcohol septal ablation, to determine patient and procedural factors associated with successful alcohol septal ablation and need for repeat procedure, and to determine the impact of conduction abnormalities after alcohol septal ablation on long-term outcomes.

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.

The primary purpose of this dose-ranging study is to assess the safety and tolerability of 3 ascending doses of LX2006 gene therapy for the purpose of selecting the appropriate dose for further clinical development. In addition, assessments of biomarkers and preliminary efficacy are included in this study.

The primary purpose of the LTFU is to assess the long-term safety and tolerability of LX2006 up to 5 years post-treatment. Additionally, efficacy assessments will be evaluated quarterly during Year 2 and annually up to 5 years post-treatment.

The standard of care for obstructive hypertrophic cardiomyopathy (HCM) refractory to medical therapy is surgical septal myectomy. Percutaneous transluminal septal myocardial ablation, otherwise known today as alcohol septal ablation (ASA) has been growing as a favorable alternative to myectomy. There have been no randomized controlled trials conducted to evaluate ASA versus surgical myectomy. The purpose of this study is to compare overall survival between surgical septal myectomy and alcohol septal ablation. The study will also compare periprocedural and long-term complication rates for both myectomy and alcohol septal ablation. Furthermore, the study willl determine the rates of re-intervention for both myectomy ...

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

The purpose of this study is to evaluate AG10 800 mg compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral response to acute sodium loading in subjects with preclinical systolic dysfunction (PSD) and renal (kidney) dysfunction.

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.

This research study is being done to help characterize cardiovascular disease and improve diagnostic tests.

OBJECTIVES

1. To understand the pathogenesis, molecular mechanisms, and disease progression of heritable cardiovascular disease

2. To evaluate the incidence of occult heritable cardiovascular disease in various populations.

3. To correlate imaging and pathological phenotype with genotype to the ends described above.

The primary purpose/objective of this study is to determine whether myectomy as a management option for severe hypertrophic cardiomyopathy (HCM) reduces the incidence of sudden cardiac death.

The purpose of this study is to determine agreement between cardiopulmonary exercise testing and cardiac stress testing (SOC) for the identification of subclinical coronary artery disease in liver transplant candidates, to determine agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (SOC) for the identification of cirrhotic cardiomyopathy in liver transplant candidates, and to determine agreement between peak oxygen consumption from cardiopulmonary exercise testing and the liver frailty index or the six-minute walk test (SOC), for the identification of frailty in liver transplant candidates.

The purpose of this study is to evaluate vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy.

The purpose of this study is to evaluate the additional benefit of pravastatin and spironolactone when given in combination with carvedilol and lisinopril versus carvedilol and lisinopril alone.

This study is an observational study to determine predictors of sudden cardiac death or appropriate ICD therapy in patients with non-ischemic cardiomyopathy. Patients will be followed for 36 months for the occurrence of sudden cardiac death

This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK and PD of AG10 compared to placebo administered on a background of stable heart failure therapy. Screening and randomization will be followed by a 28-day blinded, placebo-controlled treatment period.

The purpose of this study is to determine how many patients suffer from sexual function problems and ascertain if they are improved or modified by cardiac surgical intervention.

The purpose of this study is to evaluate the effectiveness and safety of patisiran in participants with Transthyretin Amyloidosis With Cardiomyopathy.

The purpose of this study is to utilize three dimensional (3D) transesophageal echocardiography (TEE) or 3D transthoracic echocardiography (TTE) to measure various mitral chordal, annular, and leaflet measurements and LV size to better understand the mechanism of regurgitation in patients with FMR.

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 assess the feasibility of enrolling, randomizing treatment strategies and retaining participants with frequent premature ventricular contractions (PVCs) and associated cardiomyopathy (CM).

This study is designed to identify genes shared between humans with hypertrophic cardiomyopathy and rhesus macaque primates who have experienced sudden cardiac death.

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

The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM) and long QT syndrome (LQTS).

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 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 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 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 determine prevalence of sleep apnea in patients with hypertrophic cardiomyopathy and the risk of atrial and ventricular arrhythmias.

The purpose of this study is to collect and review the Mayo Clinic experience with left cardiac sympathetic denervation (LCSD) in patients with heritable arrhythmias syndromes or refractory ventricular arrhythmias beginning in 2000.

The purpose of this study is to determine the incidence of atrial and ventricular arrhythmias in patients with hypertrophic cardiomyopathy, with and without sleep apnea.

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.

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.

The overall goal of this study is to investigate the use of artificial intelligence (AI) techniques as a screening tool for cardiomyopathies in pregnancy and the post-partum period.

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 objective of this study is to determine the utility and accuracy of patients utilizing the About Me pedigree tool to create their own pedigrees for use in risk assessment in a cardiovascular genetics clinic. 

The purpose of this study is to compare ejection hemodynamics in patients with obstructive hypertrophic cardiomyopathy (HCM) before and after septal myectomy.

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.

This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders under study. The blood tests involve analysis for von Willebrand Factor antigen and activity, von Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The results of the blood tests will be compared to the information from the clinically-indicated echocardiogram and one blood test compared to another.

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) 

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.