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New heart drug aficamten shows promise for japanese patients with thick heart muscle

NCT ID NCT07023341

Disease control Sponsor: Bayer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial is testing a drug called aficamten in 36 Japanese adults with symptomatic obstructive hypertrophic cardiomyopathy, a condition where the heart muscle thickens and makes it hard to pump blood. The drug aims to reduce over-contraction of the heart muscle. Researchers will measure changes in heart blood flow and quality of life after 6 months of treatment, and participants can continue the drug long-term if it helps.

What this could mean

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

Active substance
aficamten (also called BAY3723113)
What this could lead to
If successful, aficamten could offer a new treatment option for Japanese people with symptomatic obstructive hypertrophic cardiomyopathy, targeting the root cause of the disease.
What could go wrong
This is a single-arm, open-label study with only 36 participants, so results may not apply broadly. Long-term safety and effectiveness are still being evaluated.

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

36 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Apr 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.

Ages

18 to 85 years

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: * Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent. * Diagnosed with HCM per the following criteria: 1. Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease and 2. Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory of: 1. ≥15 mm in one or more myocardial segments OR 2. ≥13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM * Has resting LVOT-G ≥ 30 mmHg and Valsalva LVOT-G =50 mmHg during screening as determined by the echocardiography core laboratory * LVEF ≥ 60% at screening as determined by the echocardiography core laboratory * NYHA Functional Class II or III at screening * Hemoglobin ≥10 g/dL at screening * Body mass index \<35 kg/m² * Japanese * Patients on beta-blockers, verapamil, diltiazem, or disopyramide/cibenzoline should have been on a stable regimen for \>6 weeks prior to the first dose of aficamten and anticipate remaining on the same medication regimen at least during the main study treatment period. Patients treated with disopyramide or cibenzoline must also be concomitantly treated with a beta blocker and/or calcium channel blocker. Exclusion Criteria: * Significant valvular heart disease (per investigator judgement) 1. Moderate-severe valvular aortic stenosis and/or regurgitation 2. Moderate-severe mitral regurgitation not due to systolic anterior motion of the mitral valve * Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (e.g., Noonan syndrome, Fabry disease, amyloidosis) * History of LV systolic dysfunction (LVEF \<45%) or stress cardiomyopathy at any time during their clinical course * Documented paroxysmal atrial fibrillation during the screening period * Paroxysmal or persistent/permanent atrial fibrillation is only excluded IF: * Rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 6 months prior to screening * Rate control and anticoagulation have not been achieved for at least 6 months prior to screening * Has been treated with SRT (surgical myectomy or percutaneous alcohol septal ablation) or cannot postpone plans for SRT until after the study period * History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening * Has received prior treatment with aficamten or mavacamten

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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.

Obstructive hypertrophic cardiomyopathy

Contacts and locations

Locations

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Hyogo Prefectural HarimaHimeji General Medical Center

    Himeji, Hyōgo, 670-8560, Japan

  • Iwate Prefectural Central Hospital

    Morioka, Iwate, 020-0066, Japan

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375, Japan

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Kochi Medical School Hospital

    Nankoku, Kochi, 783-8505, Japan

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 710-8602, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Matsushita Memorial Hospital

    Moriguchi, Osaka, 570-8540, Japan

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507, Japan

  • National Cerebral and Cardiovascular Center

    Suita, Osaka, 564-8565, Japan

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8602, Japan

  • SHOWA Medical University Fujigaoka Hospital

    Yokohama, Kanagawa, 227-8501, Japan

  • Saiseikai Fukuoka General Hospital

    Fukuoka, 810-0001, Japan

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193, Japan

  • Sakakibara Heart Institute

    Fuchū, Tokyo, 183-0003, Japan

  • Showa Medical University Koto Toyosu Hospital

    Koto-ku, Tokyo, 135-8577, Japan

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871, Japan

  • The University of Tokyo Hospital

    Bunkyo, Tokyo, 113-8655, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576, Japan

  • University of the Ryukyus Hospital

    Ginowan, Okinawa, 901-2725, Japan

More trials for these conditions

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