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New heart drug tested in real-world chinese patients

NCT ID NCT07361289

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how well the drug mavacamten works for Chinese adults with obstructive hypertrophic cardiomyopathy, a condition where the heart muscle is too thick. About 500 people will be followed in regular clinic settings. The main goal is to see if the drug improves blood flow out of the heart.

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.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Aug 2028

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.

Who is studied

The study population will consist of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy that have received mavacamten treatment in China

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: * Participants aged ≥ 18 years (participants enrolled retrospectively: at the time of initial mavacamten prescription), irrespective of gender. * Participants who have initiated mavacamten (for whom enrolled retrospectively) or are scheduled to initiate mavacamten (for whom enrolled prospectively) based on clinical therapeutic needs. * Diagnosed with obstructive hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese guidelines for diagnosis and treatment of patients with hypertrophic cardiomyopathy, i.e., satisfy criteria below: * Has a documented diagnosis of HCM prior to enrollment, and * Peak left ventricular outflow tract (LVOT) gradient ≥ 30 mmHg at rest or with provocation in the most recent medical record within 3 months prior to enrollment as assessed by echocardiography. * Has documented left ventricular ejection fraction (LVEF) ≥ 55%, as measured by resting transthoracic echocardiography (TTE) in the most recent medical record within 3 months prior to enrollment. * New York Heart Association (NYHA) class II or III symptoms in the most recent medical record within 3 months prior to enrollment. * For participants enrolled retrospectively, essential baseline information\* and critical data\*\* must be traceable and available. At least one key follow-up time points\*\*\* is required for inclusion. Note： \* Essential baseline information, including age, gender, resting or provoked LVOT peak gradient, LVEF, indices of cardiac structure (e.g., maximum LV wall thickness, atrial and ventricular chamber size and volumes), as well as systolic and diastolic function, NYHA functional class. * Critical data, including resting or provoked LVOT gradient, LVEF, cardiac structure, systolic and diastolic function, dose of mavacamten. * Key follow-up time points: including weeks 4, 8, 12, 24, 36, 48, 72 and 96. * Voluntary sign informed consent form. Note: For participants enrolled retrospectively, the most recent medical record within 3 months as mentioned in the above requirements refer to the most recent medical record within 3 months prior to the initial mavacamten prescription. Exclusion Criteria: * Known HCM phenocopy disease (e.g., Fabry disease, amyloidosis). * Participants who are expected to undergo major cardiac surgery during the study. * Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\] or septal radiofrequency ablation) within 6 months prior to enrollment (participants enrolled retrospectively: within 6 months prior to initial mavacamten prescription); participants with an unsuccessful myectomy or percutaneous ASA or septal radiofrequency ablation performed \>6 months prior to enrollment (participants enrolled retrospectively: within 6 months prior to initial mavacamten prescription) may be enrolled. * Currently treated with disopyramide or ranolazine (within 14 days prior to enrollment \[participants enrolled retrospectively: within 14 days prior to initial mavacamten prescription\]) or participants who are expected to be taking disopyramide, ranolazine, verapamil in combination with β-receptor blockers, or diltiazem in combination with β-receptor blockers during the study. * Presence of other diseases that may affect completion of 96 weeks follow-up as assessed by the investigator. * Participants who are using or are expected to be using moderate to strong CYP2C19 inhibitors/inducers, or strong CYP3A4 inhibitors, moderate to strong CYP3A4 inducers during the study. * Participants who are participating in other interventional clinical studies.

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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.

Hypertrophic cardiomyopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Local Institution - 0003

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, 150086, China

  • Local Institution - 0005

    NOT_YET_RECRUITING

    Dalian, Liaoning, 116011, China

  • Local Institution - 0007

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450052, China

  • Local Institution - 0008

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100029, China

  • Local Institution - 0009

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Local Institution - 0010

    NOT_YET_RECRUITING

    Jinan, 250012, China

  • Local Institution - 0013

    WITHDRAWN

    Xi'an, Shan3xi, 710061, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100032, China

  • Peking University First Affiliated Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Suzhou Municipal Hospital

    RECRUITING

    Suzhou, Jiangsu, 215002, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • The Second Afilliated Hospital of Hebei Medical University

    RECRUITING

    Jiazhuang, Hebei, 050000, China

  • The Second Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130041, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, 200032, China

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