Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

One pill to shield the heart? a polypill aims to prevent heart failure in diabetes

NCT ID NCT06143566

Prevention 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial tests whether a single polypill combining three medications—finerenone, empagliflozin, and losartan—can help prevent heart failure and maintain exercise capacity in people with type 2 diabetes who are at high risk. Participants will take either the polypill or the same three drugs separately for six months. The study will measure changes in peak oxygen uptake during exercise and how well people stick to their medication.

What this could mean

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

Active substance
A combination pill containing finerenone, empagliflozin, and losartan
What this could lead to
If successful, this could offer a simple, once-daily pill to help prevent heart failure and preserve exercise capacity in people with type 2 diabetes at high risk.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. The polypill may not improve adherence or outcomes as hoped, and there are potential side effects from the medications.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 200 people

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

Started

Mar 2024

Expected to finish

Dec 2027

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 to 100 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: * Patients with Type 2 DM * History of chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) of 25 to 90 per minute per 1.73 m2 of body-surface area (stage 2 to 4 CKD) with a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of less than 5000 * With either a: High risk of HF as defined by High Watch-DM score (≥11) or Elevated natriuretic peptides or Diastolic dysfunction or left ventricular hypertrophy on echocardiography Exclusion Criteria: * eGFR \< 25 * Congestive heart failure * Hyperkalemia \> 5.0 * Contraindication to any component of polypill * Pregnancy * Creatinine \>2.0mg/dL in men and \>1.8mg/dL in women * Inability to calculate WATCH-DM score * Inability to undergo exercise testing

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for High blood pressure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Diabetic Cardiomyopathies hypertensive disorder type 2 diabetes mellitus heart failure prevention target

As listed by the trial registrant

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

High blood pressure Type 2 diabetes

How to take part

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

  1. The places running it

    1 site. 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

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

More trials for these conditions

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