A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Completed · Phase 3 · Has a placebo group

Conditions studied: Cardiomyopathy, Hypertrophic

In brief

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).

Key facts

Study ID

NCT05582395

Run by

Bristol-Myers Squibb

People needed

580

Starts

2022-12-14

Expected to finish

2025-10-20

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0041 — Málaga, Spain
• Local Institution - 0031 — Salamanca, Spain
• Local Institution - 0051 — Seville, Spain
• Local Institution - 0027 — Valencia, Spain
• Local Institution - 0445 — London, Greater London, United Kingdom
• Local Institution - 0073 — Glasgow, Lanarkshire, United Kingdom
• Local Institution - 0407 — Birmingham, United Kingdom
• Local Institution - 0472 — London, United Kingdom
• Local Institution - 0553 — Beijing, China
• Local Institution - 0208 — Himeji-Shi, Hyōgo, Japan
• Local Institution - 0082 — Birmingham, Alabama, United States
• Local Institution - 0458 — Phoenix, Arizona, United States
• Local Institution - 0409 — La Jolla, California, United States
• Local Institution - 0010 — Los Angeles, California, United States
• Local Institution - 0406 — San Francisco, California, United States
• Local Institution - 0079 — Stanford, California, United States
• Local Institution - 0468 — Gainesville, Florida, United States
• Local Institution - 0281 — Tampa, Florida, United States
• Local Institution - 0092 — Atlanta, Georgia, United States
• Local Institution - 0424 — Indianapolis, Indiana, United States
• Local Institution - 0070 — Iowa City, Iowa, United States
• Local Institution - 0410 — Kansas City, Kansas, United States
• Local Institution - 0484 — Louisville, Kentucky, United States
• Local Institution - 0127 — Baltimore, Maryland, United States
• Local Institution - 0421 — Madrid, Spain

Full record on ClinicalTrials.gov

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