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Recruiting

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

Updated: 10 May, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 4

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 9

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Mavacamten
Drug: Mavacamten
Placebo Comparator: Placebo
Other: Placebo

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 mm Hg and ≥ 50 mm Hg 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) Note: Other protocol-defined inclusion/exclusion criteria apply

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