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Heart drug mavacamten under microscope: can it reshape damaged heart muscle?

NCT ID NCT06112743

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 4 times

Summary

This phase 4 study tests the drug mavacamten in 63 adults with a type of heart muscle disease called obstructive hypertrophic cardiomyopathy. The goal is to see if the drug can improve heart structure, measured by MRI, and ease symptoms like shortness of breath. Participants take mavacamten for 48 weeks, and researchers track changes in heart chamber size and muscle thickness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mavacamten
What this could lead to
If successful, this could show that mavacamten improves heart structure and function, potentially leading to better symptom control and quality of life for people with this condition.
What could go wrong
This is a small, single-arm study with no placebo group, so results may be less reliable. The drug may not produce meaningful changes in heart structure or symptoms for all participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

63 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:. * Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise. * Left ventricular ejection fraction (LVEF) ≥ 55% at rest. * New York Heart Association (NYHA) functional class II or III symptoms. Exclusion Criteria * A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM. * Documented obstructive coronary artery disease or history of myocardial infarction. * A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening. * An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR). * Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

hypertrophic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiomyopathy, hypertrophic

Contacts and locations

Locations

  • Local Institution - 0001

    Montreal, Quebec, H1T 1C8, Canada

  • Local Institution - 0003

    Atlanta, Georgia, 30309, United States

  • Local Institution - 0005

    Melbourne, Victoria, 3004, Australia

  • Local Institution - 0015

    Camperdown, New South Wales, 2050, Australia

  • Local Institution - 0017

    Houston, Texas, 77030, United States

  • Local Institution - 0024

    Zürich (de), 8091, Switzerland

  • Local Institution - 0025

    Leeds, Yorkshire, LS1 3EX, United Kingdom

  • Local Institution - 0029

    Lugano, Ticino (it), 6900, Switzerland

  • Local Institution - 0035

    Murray, Utah, 84107-5701, United States

  • Local Institution - 0058

    Lucerne, Luzern (de), 6000, Switzerland

  • Local Institution - 0061

    Geneva, 1205, Switzerland

  • Local Institution - 0068

    Québec, Quebec, G1V 4G5, Canada

  • Local Institution - 0074

    Rosario, Santa Fe Province, S2000GAP, Argentina

  • Local Institution - 0075

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1428ART, Argentina

  • Local Institution - 0076

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1093, Argentina

  • Local Institution - 0077

    Córdoba, Córdoba Province, X5021FPQ, Argentina

  • Local Institution - 0079

    Pilar, Buenos Aires, B1629ODT, Argentina

  • Local Institution - 0080

    Buenos Aires, 1199, Argentina

  • Local Institution - 0085

    Chermside, Queensland, 4032, Australia

  • Local Institution - 0086

    Pittsburgh, Pennsylvania, 15212-4756, United States

  • Local Institution - 0087

    West Hollywood, California, 90048-1804, United States

  • Local Institution - 0090

    Cleveland, Ohio, 44106, United States

  • Local Institution - 0093

    Boston, Massachusetts, 02114, United States

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