A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
Trial Parameters
Brief 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 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 Cri