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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Cardiomyopathy, Hypertrophic

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 car...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 24 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 9 2026

    Estimated Enrollment :

    63 Patients enrolled

    Trial Details

    Trial ID

    NCT06112743

    Start Date

    January 24 2024

    End Date

    July 9 2026

    Last Update

    September 22 2025

    Active Locations (23)

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    Page 1 of 6 (23 locations)

    1

    Local Institution - 0087

    West Hollywood, California, United States, 90048-1804

    2

    Local Institution - 0003

    Atlanta, Georgia, United States, 30309

    3

    Local Institution - 0093

    Boston, Massachusetts, United States, 02114

    4

    Local Institution - 0090

    Cleveland, Ohio, United States, 44106