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One pill to treat heart failure? new study tests simpler approach

NCT ID NCT04633005

Disease control Sponsor: University of Texas Southwestern Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a single daily pill containing three heart failure drugs could help people with reduced ejection fraction, especially those with low income or from minority groups. 212 adults took either the polypill or standard separate medications. The goal was to see if the polypill made it easier to stick with treatment and improve 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
Polypill (metoprolol succinate, empagliflozin, spironolactone)
What this could lead to
If successful, this could offer a simpler, cheaper way to manage heart failure, especially for low-income and minority patients.
What could go wrong
This is a small, early-phase trial (212 people) testing feasibility, not yet proven to improve outcomes. The polypill may not suit everyone or have side effects.

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

212 people

The number who actually took part.

Started

Nov 2021

Finished

Oct 2025

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: * Adults age \> = 18 years * HF with left ventricular ejection fraction \<= 40% within 3 months of screening who are not on target dose guideline directed medical therapy * New York Heart Association class II, III, or IV symptoms Exclusion Criteria: * Age \< 18 * Systolic blood pressure \< 110 mm Hg at enrollment if not on HTN therapy. * Systolic blood pressure \<100 mm Hg at enrollment if on HTN therapy * Serum creatinine \>2.5 for men and 2.0 for women * Serum potassium \> 5.0 mEq/L * Current need for inotropes * Cardiac index \< 2.2 L/min/m2 * History of revascularization within 30 days or plan for revascularization * History of type 1 diabetes mellitus * History of allergic reaction or contraindication to a beta-blocker (BB), mineralocorticoid receptor antagonist (MRA), or sodium glucose cotransporter 2 inhibitor (SGLT2i) * Contraindication to receive any of the components of the polypill * Pregnancy * \< 6 month expected survival * Inability to provide written informed consent * Persistent or permanent atrial fibrillation who may not have optimal MRI imaging * Extreme obesity (BMI \> 45 kg/m2) * ICD/Pacemaker devices that are incompatible with MRI

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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

Contacts and locations

Locations

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75209, United States

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