NCT07004972Active, not recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 26 May 2025
- Start date
- 4 Sept 2025
- Primary completion date
- 13 Dec 2027
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07004972
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 4 Sept 2025 to the primary completion date, 13 Dec 2027
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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 documented obstructive coronary artery disease (\> 70% stenosis in one or more epicardial coronary arteries) or history of myocardial infarction.
Other
- Has paroxysmal atrial fibrillation present per the investigator's evaluation of the participant's ECG at the time of screening.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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 or with Valsalva maneuver.
- Has LVOT peak gradient with Valsalva maneuver 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.