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  • NCT06112743

Recruiting

A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy - CV027-1088

Updated: 19 December, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 4

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 21

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Mavacamten
Drug: Mavacamten

Key Eligibility Criteria

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.

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