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New heart pill aims to ease thick heart muscle symptoms

NCT ID NCT04219826

Disease control Sponsor: Cytokinetics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new daily pill called CK-3773274 (aficamten) in 96 adults with symptomatic hypertrophic cardiomyopathy, a condition where the heart muscle is abnormally thick. The goal was to find the right dose and check safety, including effects on heart pumping strength. Participants took either the drug or a placebo for 10 weeks, and researchers monitored side effects and heart function.

What this could mean

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

Active substance
CK-3773274 (aficamten) tablets taken by mouth once daily
What this could lead to
If it works, this could lead to a new daily pill to control symptoms and improve heart function in people with hypertrophic cardiomyopathy.
What could go wrong
This is a small, early-phase trial focused on safety and dosing, not proof of effectiveness. The drug may not work better than placebo or could cause side effects like reduced heart pumping function.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

96 people

The number who actually took part.

Started

Jan 2020

Finished

Feb 2023

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 * Males and females between 18 and 85 years of age at screening. * Body weight is ≥45 kg at screening. * Diagnosed with HCM per the following criteria: * Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease. * Has minimal wall thickness ≥15 mm (minimal wall thickness ≥13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation). * Adequate acoustic windows for echocardiography. * For Cohorts 1, 2 and 3 has LVOT-G during screening as follows: * Resting gradient ≥50 mmHg OR * Resting gradient ≥30 mmHg and \<50 mmHg with post-Valsalva LVOT-G ≥50 mmHg * For Cohort 4 has resting and post-Valsalva LVOT-G \< 30 mmHg at the time of screening * For Cohort 4 has elevated NT-proBNP \> 300 pg/mL at the time of screening * LVEF ≥60% at screening. * New York Heart Association (NYHA) Class II or III at screening. * Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for \>4 weeks prior to randomization and anticipate remaining on the same medication regimen during the study. * For Cohort 3: Patients must be taking disopyramide. Patients should have been on stable disopyramide doses for \>4 weeks prior to screening and anticipate remaining on the same medication regimen during the study. Exclusion Criteria * Aortic stenosis or fixed subaortic obstruction. * Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis). * History of LV systolic dysfunction (LVEF \<45%) at any time during their clinical course. * Documented history of current obstructive coronary artery disease (\>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction. * Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period (Cohorts 1, 2, and 3 only). Patients having undergone septal reduction therapy \> 12 months prior to screening who remain symptomatic from nHCM, and who meet all other criteria for inclusion, may be enrolled in Cohort 4. * For Cohorts 1, 2 and 4: Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening. (For Cohort 3, use of disopyramide is required). * Has any ECG abnormality considered by the investigator to pose a risk to patient safety (eg, second degree atrioventricular block type II). * Paroxysmal atrial fibrillation or flutter documented during the screening period. * Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for \>6 months). * History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening. * Has received prior treatment with CK-3773274 or mavacamten. * For Cohort 4: has any documented history of LVOT-G ≥ 30 mmHg at rest, with Valsalva, or with exercise (for subjects who have had prior septal reduction therapy, this exclusion criteria only applies to gradients detected following septal reduction therapy).

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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 (HCM)

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Careggi

    Florence, Italy

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Cedar-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15003, Spain

  • Duke Cardiology at Southpoint

    Durham, North Carolina, 27713, United States

  • Erasmus University Medical Center (Erasmus MC)

    Rotterdam, Netherlands

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, Spain

  • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Michigan Medicine - University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • New York University Langone Health Medical Center

    New York, New York, 10016, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • UMPC Heart and Vascular Institute

    Pittsburgh, Pennsylvania, 15213, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22903, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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