A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Purpose

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).

Condition

  • Cardiomyopathy, Hypertrophic

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mavacamten
  • Drug: Mavacamten
    Specified dose on specified days
    Other names:
    • BMS-986427
    • MYK-461
Placebo Comparator
Placebo
  • Other: Placebo
    Specified dose on specified days

More Details

Status
Active, not recruiting
Sponsor
Bristol-Myers Squibb

Study Contact