The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
580
Specified dose on specified days
Specified dose on specified days
Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48
Time frame: Up to Week 48
Change from baseline in peak oxygen consumption (pVO2) at Week 48
Time frame: Up to Week 48
Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 48
Time frame: Up to Week 48
Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 48
Time frame: Up to Week 48
Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48
Time frame: Up to Week 48
Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48
Time frame: Up to Week 48
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Local Institution - 0082
Birmingham, Alabama, United States
Local Institution - 0458
Phoenix, Arizona, United States
Local Institution - 0409
La Jolla, California, United States
Local Institution - 0010
Los Angeles, California, United States
Local Institution - 0406
San Francisco, California, United States
Local Institution - 0079
Stanford, California, United States
Local Institution - 0468
Gainesville, Florida, United States
Local Institution - 0281
Tampa, Florida, United States
Local Institution - 0092
Atlanta, Georgia, United States
Local Institution - 0424
Indianapolis, Indiana, United States
...and 214 more locations