A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Phase 3

Active, not recruiting

• Conditions: Cardiomyopathy, Hypertrophic
• Interventions: Drug: Mavacamten; Other: Placebo

• Registration Number: NCT05582395
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-17
• Study Start: 2022-12-14
• Primary Completion: 2025-03-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Study Completion: 2029-06-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mavacamten	Mavacamten	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in peak oxygen consumption (pVO2) at Week 48	Up to Week 48
Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48	Up to Week 48

Secondary Outcome Measures

Name	Time	Method
Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 48	Up to Week 48
Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 48	Up to Week 48
Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48	Up to Week 48
Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48	Up to Week 48

Trial Locations

Locations (224)

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

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