Clinical trials: Mavacamten
Healthy Participants
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.
- Trial name
- NCT05719805
- Testing
- Mavacamten
- Where
- 2 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- 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
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic obstructive cardiomyopathy (HOCM) is a heritable heart condition that leads to the thickening of the heart muscle and causes obstruction of blood flow, impeding it's ejection from the heart (LVOT obstruction).
- Conditions
- Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction, Myocardial Ischaemia
- Trial name
- PEACH (NCT07120776)
- Testing
- Camzyos (Mavacamten)
- Where
- United Kingdom
- Volunteers
- 75 people
- Sponsor
- University of Manchester
Cardiomyopathy, Hypertrophic Obstructive
IMPACT-CMH: Impact of Mitral Valve and Subvalvular Abnormalities in Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten
The objective of this observational study is to evaluate the association between the presence of mitral valvular and/or subvalvular anatomical abnormalities prior to initiation of mavacamten and the hemodynamic response at 6…
- Trial name
- IMPACT-CMH (NCT07716826)
- Volunteers
- 150 people
- Sponsor
- French Cardiology Society
Hypertrophic Cardiomyopathy (HCM)
Precision Pharmacogenetics and Genotype Class Based Prediction of Mavacamten Response in Obstructive Hypertrophic Cardiomyopathy
This research study, aims to understand why a specific heart medication called mavacamten works better for some people with hypertrophic cardiomyopathy (HCM) than for others. We believe the answer might be in our genes.
- Trial name
- PRO-Gene Mava (NCT07408427)
- Testing
- Observational study, no new intervention offered
- Where
- United Kingdom
- Volunteers
- 140 people
- Sponsor
- University of Manchester
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
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Biological Collection for the Purpose of Exploring Genetic and Clinical-biological Factors Associated With Variability in Response to Mavacamten in the Treatment of Obstructive Hypertrophic Cardiomyopathy
The European Medicines Agency has required pre-treatment genotyping of CYP2C19 to determine the initial and maximum dosage, in order to avoid overexposure to mavacamten associated with a decrease in ventricular ejection fraction…
- Trial name
- MAVA PG (NCT07439952)
- Where
- 3 sites in France
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Real-World Effectiveness of Mavacamten in Canada
The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM)…
- Trial name
- MAVEN (NCT06338202)
- Testing
- Mavacamten
- Where
- Canada
- Volunteers
- 115 people
- Sponsor
- Bristol-Myers Squibb
Cardiomyopathy, Hypertrophic
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York…
- Trial name
- MEMENTO (NCT06112743)
- Testing
- Mavacamten
- Where
- 23 sites in United States, Argentina and 4 more
- Volunteers
- 63 people
- Sponsor
- Bristol-Myers Squibb
Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy
A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.
- Conditions
- Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy, Non-obstructive Hypertrophic Cardiomyopathy
- Trial name
- NCT03723655
- Testing
- mavacamten
- Where
- 68 sites in United States, Belgium and 11 more
- Volunteers
- 314 people
- Sponsor
- Bristol-Myers Squibb
Hypertrophic Cardiomyopathy (HCM), Cardiac Myosin Inhibitors
Radiomics Analysis of CMR Imaging for Arrhythmic Risk Prediction in Hypertrophic Cardiomyopathy, With Longitudinal Risk Reassessment After Mavacamten Therapy in Obstructive Patients
Hypertrophic cardiomyopathy (HCM) is one of the leading causes of sudden cardiac death (SCD), particularly in young and middle-aged individuals.
- Trial name
- RADIOMICS-OHCM (NCT07695272)
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- Centro Cardiologico Monzino
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
Breastfeeding, Hypertrophic Cardiomyopathy
Mavacamten Pregnancy Surveillance Program
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
- Conditions
- Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related
- Trial name
- NCT05939700
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic…
- Trial name
- DISCOVER-HCM (NCT05489705)
- Testing
- Mavacamten, Non-mavacamten symptomatic oHCM therapy
- Where
- 101 sites in United States, Austria and 7 more
- Volunteers
- 1,700 people
- Sponsor
- Bristol-Myers Squibb
Cardiomyopathy, Hypertrophic
Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy
Patients with hypertrophic obstructive cardiomyopathy and New York Heart Association Class I-II under stable treatment with mavacamten (at least 12 weeks without change of dosage) and a peak left ventricular outflow tract…
- Trial name
- MavaEnEx (NCT07077005)
- Testing
- Exercise training
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Technical University of Munich
Hypertrophic Cardiomyopathy (HCM)
Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
This is an investigator-initiated two-center study. The goal of this study is to investigate the feasibility, safety and efficacy outcomes of a seamless transition from mavacamten to aficamten in patients with obstructive…
- Trial name
- CMI-SWITCH (NCT07600177)
- Testing
- Aficamten
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Oregon Health and Science University
Cardiomyopathy, Hypertrophic
A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT06253221
- Testing
- Mavacamten
- Where
- 47 sites in United States, Australia and 7 more
- Volunteers
- 44 people
- Sponsor
- Bristol-Myers Squibb
HOCM, Hypertrophic Obstructive Cardiomyopathy
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures…
- Trial name
- VALOR-HCM (NCT04349072)
- Testing
- Mavacamten
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
The study will describe how mavacamten is used in routine care for Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), including use as monotherapy or with other background/concomitant oHCM medications.
- Trial name
- REMAP-HCM (NCT07846059)
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Bristol-Myers Squibb
Healthy Participants
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.
- Trial name
- NCT05320094
- Testing
- Mavacamten, Activated Charcoal with Sorbitol
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb