A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER) (NCT07004972) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
India50 participantsStarted 2025-09-04
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.
Who can participate
Age range18 Years
SexALL
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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 screenin…
What they're measuring
1
Incidence of serious Treatment Emergent Adverse Events (TEAEs)