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Clinical Trials in India / NCT07004972
Active, not recruiting Phase 4

A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)

NCT07004972 · tracked via the Priya Life Science India tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 4
Started
2025-09-04
Last updated
2026-04-28

Condition(s) studied

Symptomatic Obstructive Hypertrophic Cardiomyopathy

Investigational drug(s) / intervention(s)

Mavacamten

Mavacamten: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * 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. Exclusion Criteria * 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. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Local Institution - 0014 Hyderabad Andhra Pradesh
Local Institution - 0011 Ahmedabad Gujarat
Local Institution - 0006 Surat Gujarat
Local Institution - 0020 Gurgaon Haryana
Medanta Heart Institute Gurgaon Haryana
Local Institution - 0004 Belagavi Karnataka
Local Institution - 0008 Mangalore Karnataka
Local Institution - 0002 Ernākulam Kerala
Local Institution - 0001 Kottayam Kerala
Local Institution - 0012 Aurangabad Maharashtra
Local Institution - 0025 Mumbai Maharashtra
Local Institution - 0025 Mumbai Maharashtra
Local Institution - 0013 Nagpur Maharashtra
Local Institution - 0019 Nagpur Maharashtra
Local Institution - 0024 Nagpur Maharashtra
Local Institution - 0010 Pune Maharashtra
Local Institution - 0021 New Delhi National Capital Territory of Delhi
Local Institution - 0005 New Delhi National Capital Territory of Delhi
Local Institution - 0007 Bikaner Rajasthan
Local Institution - 0003 Chennai Tamil Nadu
Local Institution - 0022 Aligarh Uttar Pradesh
Laxmipat Singhania Institute of Cardiology Kanpur Uttar Pradesh
Local Institution - 0023 Kanpur Uttar Pradesh
Local Institution - 0017 Kolkata West Bengal
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07004972 on ClinicalTrials.gov ↗ ← All trials in India