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One pill to rule them all: new study aims to simplify heart failure treatment

NCT ID NCT07569640

Disease control Sponsor: Washington University School of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 6 times

Summary

This study tests whether a single pill containing four standard heart failure medications can help patients take their medicines more regularly and reduce hospitalizations and death. About 1,656 adults with heart failure and reduced pumping function will be randomly assigned to receive either the combination pill or usual care. The trial will track heart-related deaths, hospital stays, side effects, and quality of life over at least one year.

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

About 1,672 people

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

Started

Aug 2026

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

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: 1. Adults (≥18 years old) 2. Diagnosis of heart failure with reduced ejection fraction (HFrEF) including clinical symptoms or clinical signs or natriuretic peptide elevation AND echocardiographic or other evidence of reduced left ventricular ejection fraction (EF ≤40%) 3. New York Heart Association Class II, III, or IV symptoms Exclusion Criteria: 1. Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others). 2. Significant renal impairment (estimated glomerular filtration rate \<30 mL/min/1.73 m2). 3. Raised serum potassium \>5 mEq/L. 4. Symptomatic hypotension or systolic BP \<100 mmHg as per the average of last 2 of the 3 measurements at visit 1. 5. Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1. 6. History of type 1 diabetes mellitus. 7. Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using a highly acceptable form of contraception throughout the study (pharmacological or barrier methods). 8. Concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary physician could interfere with the conduct of the study including outcome assessment. 9. Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible. 10. Participant's responsible physician believes it is not appropriate for participant to participate in the study. 11. Inability or unwillingness to provide written informed consent. 12. Involvement in the planning and/or conduct of the study. 13. Unable to complete study procedures and/or plan to move out of the study site area in the next 12 months.

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Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure with reduced ejection fraction

How to take part

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

  1. The places running it

    11 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

  • Colombo North Teaching Hospital

    RECRUITING

    Ragama, Western Province, 11010, Sri Lanka

  • Colombo South Teaching Hospital

    RECRUITING

    Dehiwala, Western Province, 10350, Sri Lanka

  • District General Hospital Negombo

    NOT_YET_RECRUITING

    Negombo, Western Province, 11500, Sri Lanka

  • Gampaha District General Hospital

    NOT_YET_RECRUITING

    Gampaha, Western Province, 11000, Sri Lanka

  • National Hospital Galle

    RECRUITING

    Galle, Southern Province, 80000, Sri Lanka

  • National Hospital Kandy

    RECRUITING

    Kandy, Central Province, 20000, Sri Lanka

  • National Hospital of Sri Lanka

    NOT_YET_RECRUITING

    Colombo, Western Province, 00100, Sri Lanka

  • Rathnapura Teaching Hospital

    NOT_YET_RECRUITING

    Colombo, Ratnapura, 70000, Sri Lanka

  • Teaching Hospital Jaffna

    RECRUITING

    Jaffna, Northern Province, 40000, Sri Lanka

  • Teaching Hospital Kurunegala

    NOT_YET_RECRUITING

    Kurunegala, North Western Province, 60000, Sri Lanka

  • University Hospital - General Sir John Kotelawala Defence University

    NOT_YET_RECRUITING

    Colombo, Western Province, 10290, Sri Lanka

More trials for these conditions

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