RecruitingPhase 4NCT07004972
A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
A Phase 4, Single-Arm, Open-Label Study to Evaluate Safety, Tolerability, and Efficacy of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy in India
Sponsor
Bristol-Myers Squibb
Enrollment
50 participants
Start Date
Sep 4, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- Diagnosed with obstructive hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines.
- Has unexplained LV hypertrophy with nondilated ventricular chambers in the absence of other cardiac (ie, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy).
- Has LVOT (Valsalva left ventricular outflow tract) peak gradient ≥ 50 mmHg during screening as assessed by TTE at rest, Valsalva maneuver, or post exercise LVOT peak gradient.
- Has LVOT peak gradient with Valsalva at screening TTE of ≥ 30 mmHg.
- Has adequate acoustic windows to enable accurate TTEs.
- Has New York Heart Association (NYHA) Class II or III symptoms at screening.
- Body weight is greater than 45 kg at screening.
- Documentation of LVEF ≥ 55% at rest of screening TTE.
Exclusion Criteria6
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics obstructive hypertrophic cardiomyopathy, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
- Has paroxysmal atrial fibrillation present per the investigator's evaluation of the participant's ECG at the time of screening.
- Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate controlled within 6 months prior to screening. (Note: Participants with persistent or permanent atrial fibrillation who are anticoagulated and adequately rate-controlled are allowed).
- Has a history of syncope with exercise within 6 months prior to screening.
- History of sustained ventricular tachyarrhythmia (\> 30 seconds) within 6 months prior to screening.
- Has documented obstructive coronary artery disease (\> 70% stenosis in one or more epicardial coronary arteries) or history of myocardial infarction.
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Interventions
DRUGMavacamten
Specified dose on specified days
Locations(31)
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NCT07004972