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New drug shows promise for stiff heart condition in japanese patients

NCT ID NCT05414175

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called mavacamten in 38 Japanese adults with a condition where the heart muscle is too thick, making it hard for the heart to pump blood. The goal was to see if the drug could improve heart function and symptoms over 30 weeks. Participants took the drug and had regular heart scans and questionnaires to track their progress.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

38 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2025

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

Accepted

You do not need to have the condition being studied to take part.

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: * Age 18 and greater, body weight ≥ 35kg * Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs) * Diagnosed with obstructive hypertrophic cardiomyopathy consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Japanese Circulation Society guidelines * Has documented left ventricular ejection fraction (LVEF) ≥60% NYHA Class II or III Exclusion Criteria: * Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy * History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening * History of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to Screening * Paroxysmal atrial fibrillation with atrial fibrillation present at the time of Screening. * Persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening * Treatment (within 14 days prior to Screening) or planned treatment during the study with cibenzoline, disopyramide or ranolazine * Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of beta blockers and verapamil or a combination of beta blockers and diltiazem * Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening or plans to have either of these treatments during the study * ICD placement within 2 months prior to Screening or planned ICD placement during the study * Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation procedures, or completion * Prior treatment with cardiotoxic agents such as doxorubicin or similar 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 obstructive

Contacts and locations

Locations

  • Local Institution - 0001

    Itabashi-Ku, Tokyo, 173-0003, Japan

  • Local Institution - 0003

    Fuchu-Shi, Tokyo, 1830003, Japan

  • Local Institution - 0005

    Shinjuku-Ku, Tokyo, 160-8582, Japan

  • Local Institution - 0007

    Koto-Ku, Tokyo, 135-0061, Japan

  • Local Institution - 0009

    Chuo-Ku, Tokyo, 104-0044, Japan

  • Local Institution - 0010

    Bunkyo-Ku, Tokyo, 113-0033, Japan

  • Local Institution - 0011

    Suita-Shi, Osaka, 565-0871, Japan

  • Local Institution - 0012

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Local Institution - 0013

    Shinjuku-ku, Tokyo, 162-8666, Japan

  • Local Institution - 0014

    Suita, Osaka, 564-8565, Japan

  • Local Institution - 0015

    Nankoku-shi, Kochi, 783-8505, Japan

  • Local Institution - 0016

    Kobe, Hyōgo, 650-0047, Japan

  • Local Institution - 0017

    Tsukuba, Ibaraki, 305-0005, Japan

  • Local Institution - 0018

    Osaka, 558-8558, Japan

  • Local Institution - 0019

    Yokohama, Kanagawa, 227-8501, Japan

  • Local Institution - 0020

    Uwajima, Ehime, 798-8510, Japan

  • Local Institution - 0023

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Local Institution - 0026

    Himeji-Shi, Hyōgo, 672-8044, Japan

  • Local Institution - 0027

    Sendai, Miyagi, 980-8574, Japan

  • Local Institution - 0028

    Tsu, Mie-ken, 514-8507, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.