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OpenTrials
Completed

NCT Number: NCT05582395

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0063, Concord, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mavacamten

Drug

Specified dose on specified days

Other names: BMS-986427, MYK-461

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48

    Time frame: Up to Week 48

  2. Change from baseline in peak oxygen consumption (pVO2) at Week 48

    Time frame: Up to Week 48

Secondary outcomes

  1. Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 48

    Time frame: Up to Week 48

  2. Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 48

    Time frame: Up to Week 48

  3. Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48

    Time frame: Up to Week 48

  4. Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48

    Time frame: Up to Week 48

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: ODYSSEY-HCM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2022
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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