A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
- Conditions
- Symptomatic Obstructive Hypertrophic Cardiomyopathy
- Interventions
- Registration Number
- NCT07004972
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mavacamten Mavacamten -
- Primary Outcome Measures
Name Time Method Incidence of serious Treatment Emergent Adverse Events (TEAEs) Up to Week 48
- Secondary Outcome Measures
Name Time Method Change from baseline to Week 30 in N-terminal pro b-type natriuretic peptide (NT-proBNP) Up to Week 30 Change from baseline to Week 30 in hs-troponin-I Up to Week 30 Change from baseline to Week 30 in Valsalva left ventricular outflow tract (LVOT) peak gradient Up to Week 30 Change from baseline to Week 30 in resting LVOT peak gradient Up to Week 30 Number of participants with major adverse cardiac events Up to Week 48 Major adverse cardiac events includes cardiovascular \[CV\] death, non-fatal stroke, nonfatal myocardial infarction and hospitalization for heart failure
Number of participants with CV hospitalization Up to Week 48 Number of participants with heart failure (HF) events Up to Week 48 HF includes HF related hospitalizations and urgent emergency room \[ER\]/outpatient visits
Number of participants with atrial fibrillation/flutter Up to Weeks 48 Number of participants with syncope Up to Week 48 Number of participants with left ventricular ejection fraction (LVEF) < 50% Up to Week 30 Number of participants with left ventricular ejection fraction (LVEF) < 45% Up to Week 30 Number of participants with left ventricular ejection fraction (LVEF) < 40% Up to Week 30 Number of participants with left ventricular ejection fraction (LVEF) < 30% Up to Week 30 Number of participants with non-serious AEs Up to Week 48 Proportion of participants with at least 1 class improvement in New York Heart Association (NYHA) functional class from baseline to Week 30 Up to Week 30 The New York Heart Association (NYHA) functional classification of heart failure assigns participants to 1 of 4 categories based on the participant's symptoms. Heart failure classification will be assessed by the Investigator at specified timepoints in the study. NYHA class at Week 30 will be compared to baseline and the proportion of participants with an improvement of at least one class will be determined.
Trial Locations
- Locations (25)
Local Institution - 0014
🇮🇳Hyderabad, Andhra Pradesh, India
Local Institution - 0021
🇮🇳New Delhi, Delhi, India
Local Institution - 0005
🇮🇳New delhi, Delhi, India
Local Institution - 0011
🇮🇳Ahmedabad, Gujarat, India
Local Institution - 0006
🇮🇳Surat, Gujarat, India
Local Institution - 0020
🇮🇳Gurgaon, Haryana, India
Local Institution - 0004
🇮🇳Belagavi, Karnataka, India
Local Institution - 0008
🇮🇳Mangalore, Karnataka, India
Local Institution - 0002
🇮🇳Ernakulam, Kerala, India
Local Institution - 0001
🇮🇳Kottayam, Kerala, India
Local Institution - 0012
🇮🇳Aurangabad, Maharashtra, India
Local Institution - 0025
🇮🇳Mumbai, Maharashtra, India
Local Institution - 0013
🇮🇳Nagpur, Maharashtra, India
Local Institution - 0019
🇮🇳Nagpur, Maharashtra, India
Local Institution - 0024
🇮🇳Nagpur, Maharashtra, India
Local Institution - 0010
🇮🇳Pune, Maharashtra, India
Local Institution - 0016
🇮🇳Bhubaneswar, Orissa, India
Local Institution - 0018
🇮🇳Cuttack, Orissa, India
Local Institution - 0015
🇮🇳Ludhiana, Punjab, India
Local Institution - 0007
🇮🇳Bikaner, Rajasthan, India
Local Institution - 0003
🇮🇳Chennai, Tamil Nadu, India
Local Institution - 0022
🇮🇳Aligarh, Uttar Pradesh, India
Local Institution - 0023
🇮🇳Kanpur, Uttar Pradesh, India
Local Institution - 0017
🇮🇳Kolkata, WEST Bengal, India
Local Institution - 0009
🇮🇳New Delhi, India