A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Phase 4

Active, not recruiting

• Conditions: Cardiomyopathy, Hypertrophic
• Interventions: Drug: Mavacamten

• Registration Number: NCT06112743
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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) \[New York Heart Association (NYHA) Functional Class II or III\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-01
• Study Start: 2024-01-24
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-07-09
• Study Completion: 2026-07-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mavacamten	Mavacamten	-

Primary Outcome Measures

Name	Time	Method
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in maximum left atrial volume index (LAVI) at Week 48	At week 48
Incidence of MACE-expanded events	Up to 48 weeks
Incidence of heart failure (HF) events	Up to 48 weeks
Incidence of HF events with systolic dysfunction	Up to 48 weeks
Change from baseline in left ventricular mass index (LVMI) at Week 48	At week 48
Incidence of major adverse cardiac events (MACE)	Up to 48 weeks
Incidence of ventricular tachyarrhythmias	Up to 48 weeks
Incidence of treatment emergent serious adverse events (SAEs)	Up to 48 weeks
TEAEs leading to laboratory abnormalities	Up to 48 weeks
Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48	At week 48
Incidence of atrial fibrillation (AF)/atrial flutter	Up to 48 weeks
Incidence of nonvasovagal syncope and seizures	Up to 48 weeks
TEAEs leading to discontinuation from study intervention	Up to 48 weeks
Incidence of treatment emergent adverse events (TEAEs)	Up to 48 weeks
Severity of TEAEs	Up to 48 weeks
All-cause mortality	Up to 48 weeks
Incidence of cardiovascular (CV) mortality	Up to 48 weeks

Trial Locations

Locations (23)

Local Institution - 0087; 🇺🇸 West Hollywood, California, United States

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

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