The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) \[New York Heart Association (NYHA) Functional Class II or III\].
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Specified dose on specified days
Local Institution - 0087
West Hollywood, California, United States
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment: * A decrease of at least 5 mL/m2 in maximum LAVI from baseline * A decrease of at least 5 g/m2 in LVMI from baseline
Time frame: At week 48
Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48
Time frame: At week 48
Change from baseline in maximum left atrial volume index (LAVI) at Week 48
Time frame: At week 48
Change from baseline in left ventricular mass index (LVMI) at Week 48
Time frame: At week 48
Incidence of major adverse cardiac events (MACE)
Time frame: Up to 48 weeks
Incidence of MACE-expanded events
Time frame: Up to 48 weeks
All-cause mortality
Time frame: Up to 48 weeks
Incidence of heart failure (HF) events
Time frame: Up to 48 weeks
Incidence of HF events with systolic dysfunction
Time frame: Up to 48 weeks
Incidence of atrial fibrillation (AF)/atrial flutter
Time frame: Up to 48 weeks
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Local Institution - 0003
Atlanta, Georgia, United States
Local Institution - 0093
Boston, Massachusetts, United States
Local Institution - 0090
Cleveland, Ohio, United States
Local Institution - 0086
Pittsburgh, Pennsylvania, United States
Local Institution - 0017
Houston, Texas, United States
Local Institution - 0035
Murray, Utah, United States
Local Institution - 0076
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0075
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0079
Pilar, Buenos Aires, Argentina
...and 13 more locations
Incidence of cardiovascular (CV) mortality
Time frame: Up to 48 weeks
Incidence of ventricular tachyarrhythmias
Time frame: Up to 48 weeks
Incidence of nonvasovagal syncope and seizures
Time frame: Up to 48 weeks
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 48 weeks
Severity of TEAEs
Time frame: Up to 48 weeks
Incidence of treatment emergent serious adverse events (SAEs)
Time frame: Up to 48 weeks
TEAEs leading to discontinuation from study intervention
Time frame: Up to 48 weeks
TEAEs leading to laboratory abnormalities
Time frame: Up to 48 weeks