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New heart failure pill shows promise in early trial

NCT ID NCT06793371

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 2 times

Summary

This study tests a new drug called CK-4021586 (ulacamten) in 60 adults with a type of heart failure where the heart pumps normally but is stiff (HFpEF). Participants take the drug or a placebo for 12 weeks to see if it is safe and how it affects heart function. The goal is to find the right dose for future studies.

What this could mean

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

Active substance
CK-4021586 (ulacamten)
What this could lead to
If successful, this could point toward a new treatment option for people with a common type of heart failure that currently has limited therapies.
What could go wrong
This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. The drug could cause side effects or fail to improve heart 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

About 60 people

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

Started

Feb 2025

Expected to finish

Sep 2026

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

40 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 ≥ 40 years and ≤ 85 years of age at screening. * Diagnosed with HF with NYHA functional class II or III. * Screening echocardiography with LVEF ≥ 60%. * Screening NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm and ≥ 900 pg/mL for participants with comorbid atrial fibrillation or flutter. * Body mass index \< 40 kg/m2. * Participants on beta-blockers, angiotensin-converting enzyme (ACE)/angiotensin II receptor blocker (ARB) or angiotensin receptor/neprilysin inhibitor (ARNI), must be on stable doses for more than 30 days prior to screening. * Participants on a glucagon-like peptide-1 (GLP-1) agonist must be on a stable dose for more than 24 weeks prior to screening with no anticipated plans to change dose during this study. Exclusion Criteria: * History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure symptomatic heart failure

As listed by the trial registrant

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

Symptomatic heart failure with preserved ejection fraction (hfpef)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • BioSolutions Clinical Research Center

    RECRUITING

    Imperial, California, 92251, United States

  • Blue Coast Research Center, LLC

    RECRUITING

    Vista, California, 92081, United States

  • Center for Advanced Heart Failure

    RECRUITING

    Houston, Texas, 77030, United States

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

  • DelRicht Research

    WITHDRAWN

    Vienna, Virginia, 22182, United States

  • Eastern Shore Research Institute, LLC

    RECRUITING

    Fairhope, Alabama, 36532, United States

  • FOMAT - Comprehensive Cardiovascular Care

    RECRUITING

    Santa Maria, California, 93454, United States

  • Froedtert Hospital - Center for Advanced Care

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • John L. McClellan Memorial Veterans Hospital

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Las Mercedes Medical Research

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Louisiana Heart Center

    WITHDRAWN

    Slidell, Louisiana, 70458, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02214, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Methodist Medical Center of Illinois

    RECRUITING

    Peoria, Illinois, 61636, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • New Generation of Medical Research

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Profound Research LLC

    RECRUITING

    Pasadena, California, 91105, United States

  • Swedish Heart & Vascular Institute, Advanced Cardiac Support Program

    RECRUITING

    Seattle, Washington, 98122, United States

  • The Lindner Center for Research & Education at The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Arizona Sarver Heart Center

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of California, San Francisco - Heart and Vascular Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Texas Southwestern Medical Center, Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

  • Washington University Center for Advanced Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States