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

Launched by BRISTOL-MYERS SQUIBB · May 26, 2025

Keywords

ClinConnect Summary

The ROVER trial is a research study looking at a medication called mavacamten for adults with a heart condition known as obstructive hypertrophic cardiomyopathy (HCM). This condition causes the heart muscle to thicken, which can make it harder for the heart to pump blood and may cause symptoms like shortness of breath or chest pain. The study aims to determine how safe and effective mavacamten is for people with this condition in India.

To participate in the trial, individuals must be diagnosed with obstructive HCM and meet certain health criteria, such as having specific measurements of heart function and experiencing certain symptoms. Participants should weigh more than 45 kg and have a certain level of heart function as assessed by an ultrasound of the heart. The trial is not yet recruiting participants, but those who qualify can expect to undergo evaluations to confirm their condition and may receive the study medication during the trial. This study could help improve treatment options for people with obstructive HCM.

Gender

ALL

Eligibility criteria

• • 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, 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 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.