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Recruiting

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy - CV027-031

Updated: 15 February, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 139

    Location(s)

  • Recruiting

Treatment Options

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

Key Eligibility Criteria

Inclusion Criteria - Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal left ventricular (LV) wall thickness ≥ 15 millimeters (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) as determined by core laboratory interpretation. - Peak left ventricular outflow tract (LVOT) pressure gradient < 30 millimeters mercury (mm Hg) at rest and < 50 mm Hg with provocation (Valsalva maneuver and stress echocardiography). - New York Heart Association (NYHA) Class II or III. Exclusion Criteria - Known infiltrative or storage disorder causing cardiac hypertrophy that mimics non-obstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy. - History of unexplained syncope within 6 months prior to screening. - History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening. - Other protocol-defined Inclusion/Exclusion criteria apply.

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