Clinical trials: Cardiomyopathies
Heart Failure With Preserved Ejection Fraction
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
This is a Phase 2a proof-of-concept study to assess safety, tolerability, and preliminary efficacy of mavacamten treatment on biomarker levels in participants with heart failure with preserved ejection fraction (HFpEF) and…
- Trial name
- EMBARK-HFpEF (NCT04766892)
- Testing
- mavacamten
- Where
- 21 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Bristol-Myers Squibb
Hypertrophic Cardiomyopathy
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
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).
- Trial name
- PIONEER-OLE (NCT03496168)
- Testing
- mavacamten
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Type 2 Diabetes, Diabetic Cardiomyopathies
IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)
The purpose of this study is to assess the activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability
- Conditions
- Type 2 Diabetes, Diabetic Cardiomyopathies, HFpEF - Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT04826159
- Testing
- IMB-1018972
- Where
- United Kingdom
- Volunteers
- 49 people
- Sponsor
- Imbria Pharmaceuticals, Inc.
Symptomatic Transthyretin Amyloid Cardiomyopathy
A Phase 3 Study of ALXN2060 in Japanese Participants With Symptomatic ATTR-CM
This prospective study is designed to evaluate the efficacy, safety, and tolerability of ALXN2060 (also known as AG10), as well as to establish its pharmacokinetic and pharmacodynamic profile in Japanese participants with…
- Trial name
- NCT04622046
- Testing
- ALXN2060
- Where
- 11 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Heart Failure
PACMAN - PAcing for CardioMyopathies, a EuropeAN Study
The purpose of this study was to evaluate the benefit of biventricular pacing in patients with heart failure who were receiving optimal pharmacological therapy, and who were either with or without an ICD indication
- Trial name
- NCT00180596
- Testing
- Contak heart failure devices
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 262 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis, Cardiomyopathy, Hypertrophic
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Trial name
- PII NR3/ViV (NCT03225001)
- Testing
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Where
- 47 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Edwards Lifesciences
Cardiomyopathy, Hypertrophic
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
- Trial name
- ODYSSEY-HCM (NCT05582395)
- Testing
- Mavacamten
- Where
- 224 sites in United States, Australia and 21 more
- Volunteers
- 580 people
- Sponsor
- Bristol-Myers Squibb
Heart Failure, Systolic
Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
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…
- Trial name
- PROVIDE-HF (NCT03387163)
- Testing
- Sacubitril/Valsartan
- Where
- United States
- Volunteers
- 402 people
- Sponsor
- Novartis Pharmaceuticals
Cardiomyopathy, Hypertrophic
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
The purpose of this study was to determine if LCZ696 can improve functional capacity (via improved peak VO2) in non-obstructive hypertrophic cardiomyopathy (HCM) patient population over the course of 50 weeks of treatment.
- Trial name
- NCT04164732
- Testing
- LCZ696
- Where
- 18 sites in United States, Germany and 4 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
This is a Phase 1/2, open-label, dose-exploration and dose-expansion, clinical trial evaluating the safety, tolerability, pharmacodynamics, and preliminary efficacy of a single intravenous infusion of AFTX-201 in adults with…
- Trial name
- UPBEAT (NCT07426419)
- Testing
- AFTX-201
- Where
- 5 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Affinia Therapeutics
Myocardial Infarction, Arrhythmia, Ventricular
MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
The purpose of the study is to determine the usefulness of Microvolt T Wave Alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart.
- Conditions
- Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy
- Trial name
- NCT00305214
- Testing
- T Wave Alternans Test
- Where
- 47 sites in United States
- Volunteers
- 405 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ischemic Heart Failure
LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry
The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator.
- Trial name
- WEARIT-III (NCT02700880)
- Testing
- LifeVest
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Zoll Medical Corporation
Hypertrophic Cardiomyopathy
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with…
- Trial name
- NCT06347159
- Testing
- EDG-7500
- Where
- 21 sites in United States
- Volunteers
- 79 people
- Sponsor
- Edgewise Therapeutics, Inc.
Friedreich Ataxia, Cardiomyopathy, Secondary
Gene Therapy for Cardiomyopathy Associated With Friedreich's Ataxia
This is a Phase 1/2, open-label, dose-ascending, multicenter study of the safety and efficacy of LX2006 for participants who have Friedreich's Ataxia with evidence of cardiomyopathy.
- Trial name
- NCT05445323
- Testing
- Low dose LX2006, Mid Dose LX2006, High Dose LX2006
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Lexeo Therapeutics
Dilated Cardiomyopathy
Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)
This study is designed to assess the safety and tolerability of Cardiac Repair Cells (CRCs) compared to standard-of-care in patients with dilated cardiomyopathy (DCM).
- Trial name
- NCT00765518
- Testing
- Ixmyelocel-T, Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Vericel Corporation
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Hypertrophic Cardiomyopathy
Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects.
- Trial name
- NCT02329184
- Testing
- MYK-461
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- MyoKardia, Inc.
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy
This study will examine the clinical effectiveness of Tafamidis in patients with Mixed Phenotype Transthyretin Amyloidosis using data that already exist in patients' medical records
- Trial name
- NCT06393465
- Testing
- Tafamidis
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Pfizer
Myocardial Reperfusion Injury
Efficacy and Safety Evaluation of PC-SOD for Injection in Reducing Myocardial Reperfusion Injury
The current study aims to evaluate different doses of PC-SOD injections for efficacy and safety in comparison to placebo, in order to provide a basis for future clinical trials in terms of experimental design and dose selection.
- Trial name
- NCT03995732
- Testing
- PC-SOD
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- Beijing Tide Pharmaceutical Co., Ltd
TTR Cardiomyopathy
A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)
The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.
- Trial name
- NCT01775761
- Testing
- Period 1, Period 2, Period 3
- Where
- 3 sites in United States, Belgium and 1 more
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Pfizer