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

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling

Phase 4

Conditions

Symptomatic Obstructive Hypertrophic Cardiomyopathy

Treatments

Drug: Mavacamten

Study type

Interventional

Funder types

Industry

Identifiers

NCT07004972

CV027-1146

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.