A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria


  1. 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.
  2. 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).
  3. New York Heart Association (NYHA) Class II or III.

EXCLUSION CRITERIA

Exclusion Criteria


  1. 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.
  2. History of unexplained syncope within 6 months prior to screening.
  3. History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening.
  4. * Other protocol-defined Inclusion/Exclusion criteria apply.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Cardiomyopathy, Hypertrophic
Age (in years)
18+
Phase
PHASE3
Participants needed
420
Est. Completion Date
Jun 29, 2029
Treatment type
INTERVENTIONAL

Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT05582395
Study number
CV027031

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