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)
Incidence of serious Treatment Emergent Adverse Events (TEAEs) — Up to Week 48
Trial sites (24)
Facility
City
Region
Status
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.
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