Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

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, 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

Additional inclusion and exclusion criteria apply.

Locations

  • University of California San Diego
    La Jolla California 92037-1337 United States
  • Harbor UCLA Medical Center
    Torrance California 90509 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting Investigator Inquiry Form FDA Safety Alerts and Recalls
ID
NCT05582395
Phase
Phase 3 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 420 study participants
Last Updated