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

NCT05582395

CompletedPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Cardiomyopathy, Hypertrophic

Interventions: Mavacamten, Placebo

Countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (224)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • Gainesville, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Kansas City, Kansas, United States
  • Louisville, Kentucky, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Morristown, New Jersey, United States
  • Manhasset, New York, United States
  • New York, New York, United States
  • Stony Brook, New York, United States
  • Valhalla, New York, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • + 194 more on CT.gov