The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Specified dose on specified days
Incidence of serious Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 48
Number of participants with major adverse cardiac events
Major adverse cardiac events includes cardiovascular \[CV\] death, non-fatal stroke, nonfatal myocardial infarction and hospitalization for heart failure
Time frame: Up to Week 48
Number of participants with CV hospitalization
Time frame: Up to Week 48
Number of participants with heart failure (HF) events
HF includes HF related hospitalizations and urgent emergency room \[ER\]/outpatient visits
Time frame: Up to Week 48
Number of participants with atrial fibrillation/flutter
Time frame: Up to Weeks 48
Number of participants with syncope
Time frame: Up to Week 48
Number of participants with left ventricular ejection fraction (LVEF) < 50%
Time frame: Up to Week 30
Number of participants with left ventricular ejection fraction (LVEF) < 45%
Time frame: Up to Week 30
Number of participants with left ventricular ejection fraction (LVEF) < 40%
Time frame: Up to Week 30
Number of participants with left ventricular ejection fraction (LVEF) < 30%
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Osmania General Hospital
Hyderabad, Andhra Pradesh, India
RECRUITINGMarengo CIMS Hospital
Ahmedabad, Gujarat, India
RECRUITINGUnicare Heart Institute (A division of Unique Hospital)
Surat, Gujarat, India
RECRUITINGMedanta Heart Institute
Gurgaon, Haryana, India
RECRUITINGKLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi, Karnataka, India
RECRUITINGOmega Hospital
Mangalore, Karnataka, India
RECRUITINGAmrita Hospital
Ernākulam, Kerala, India
RECRUITINGCaritas Hospital
Kottayam, Kerala, India
RECRUITINGORIION Citicare Superspeciality Hospital
Aurangabad, Maharashtra, India
RECRUITINGKing Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
Mumbai, Maharashtra, India
RECRUITING...and 19 more locations
Time frame: Up to Week 30
Number of participants with non-serious AEs
Time frame: Up to Week 48
Change from baseline to Week 30 in Valsalva left ventricular outflow tract (LVOT) peak gradient
Time frame: Up to Week 30
Change from baseline to Week 30 in resting LVOT peak gradient
Time frame: Up to Week 30
Change from baseline to Week 30 in hs-troponin-I
Time frame: Up to Week 30
Change from baseline to Week 30 in N-terminal pro b-type natriuretic peptide (NT-proBNP)
Time frame: Up to Week 30
Proportion of participants with at least 1 class improvement in New York Heart Association (NYHA) functional class from baseline 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.
Time frame: Up to Week 30