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Trial ID CV027-031  |   NCT05582395

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • 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.
    1. 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).
      1. New York Heart Association (NYHA) Class II or III.

        Exclusion Criteria

        Exclusion Criteria Icon
        • 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.
          1. History of unexplained syncope within 6 months prior to screening.
            1. History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening.
              Additional Information *
              • 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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