A Phase 4 interventional study of Mavacamten in Cardiomyopathy, Hypertrophic, sponsored by Bristol-Myers Squibb. Active, not recruiting at 23 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Bristol-Myers Squibb · Phase 4, Interventional, and Treatment
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].
347 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 110 are open to participants now.
This study's enrollment of 63 is close to the median of 59 across 171 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Drug: Mavacamten
Specified dose on specified days
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
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
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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