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Clinical Trials in the USA / NCT06112743
Active, not recruiting Phase 4

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

NCT06112743 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 4
Started
2024-01-24
Last updated
2026-09-16

Condition(s) studied

Cardiomyopathy, Hypertrophic

Investigational drug(s) / intervention(s)

Mavacamten →

Mavacamten: Specified dose on specified days

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:. * Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise. * Left ventricular ejection fraction (LVEF) ≥ 55% at rest. * New York Heart Association (NYHA) functional class II or III symptoms. Exclusion Criteria * A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM. * Documented obstructive coronary artery disease or history of myocardial infarction. * A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening. * An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR). * Other protocol-defined inclusion/exclusion criteria apply.

Primary outcome measure(s)

  • 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

Trial sites (23)

FacilityCityRegionStatus
Local Institution - 0087 West Hollywood California
Local Institution - 0003 Atlanta Georgia
Local Institution - 0093 Boston Massachusetts
Local Institution - 0090 Cleveland Ohio
Local Institution - 0086 Pittsburgh Pennsylvania
Local Institution - 0017 Houston Texas
Local Institution - 0035 Murray Utah
Local Institution - 0076 Ciudad Autónoma de Buenos Aires Buenos Aires
Local Institution - 0075 Ciudad Autónoma de Buenos Aires Buenos Aires
Local Institution - 0079 Pilar Buenos Aires
Local Institution - 0077 Córdoba Córdoba Province
Local Institution - 0074 Rosario Santa Fe Province
Local Institution - 0080 Buenos Aires Argentina
Local Institution - 0015 Camperdown New South Wales
Local Institution - 0085 Chermside Queensland
Local Institution - 0005 Melbourne Victoria
Local Institution - 0001 Montreal Quebec
Local Institution - 0068 Québec Quebec
Local Institution - 0058 Lucerne Luzern (de)
Local Institution - 0029 Lugano Ticino (it)
Local Institution - 0061 Geneva Switzerland
Local Institution - 0024 Zürich (de) Switzerland
Local Institution - 0025 Leeds Yorkshire

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Other trials for the same condition

A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06112743 on ClinicalTrials.gov ↗ ← All trials in the USA