Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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).

Official Title

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy

Keywords

Cardiomyopathy, Hypertrophic, Mavacamten, non-obstructive HCM, non-obstructive hypertrophic cardiomyopathy (nHCM), Cardiomyopathies, Hypertrophic Cardiomyopathy, Hypertrophy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • UCSF School of Medicine accepting new patients
    San Francisco California 94143-2204 United States
  • Stanford University accepting new patients
    Palo Alto California 94304 United States
  • Stanford Health Care (SHC) - Hypertrophic Cardiomy withdrawn
    Stanford California 94305-2200 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
ID
NCT05582395
Phase
Phase 3 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 420 study participants
Last Updated