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Trial ID CV027-1088  |   NCT06112743

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

Summary

  • Phase 4
  • Male and Female Gender icon
  • 18+
    Age Range
  • 9
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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].

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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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Mavacamten

ASSIGNED INTERVENTION
  • Drug: Mavacamten

Study Arms

Placebo Comparator: Placebo

ASSIGNED INTERVENTION
  • Other: Placebo
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