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Could a common diabetes drug help adult heart defect patients?

NCT ID NCT06260059

Disease control Sponsor: Anita Saraf 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 2 times

Summary

This study tests whether Empagliflozin (Jardiance), a drug used for diabetes and heart failure, can help adults born with heart defects who now have a weakened heart. Forty participants will receive either the drug or a placebo for one year. Researchers will measure changes in heart function, exercise ability, and hospitalizations.

What this could mean

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

Active substance
Empagliflozin (Jardiance)
What this could lead to
If it works, this could point toward a new treatment option for adults with congenital heart disease who develop heart failure.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. The drug may not improve heart function or exercise capacity as hoped.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

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

Started

Sep 2024

Expected to finish

Jun 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 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: * Diagnoses of Congenital Heart Disease * Age 18+ * ACHD level of structural complexity II or III * Recent (\<6 months) decrease in systemic Ejection Fraction (confirmed by cardiac Echocardiogram, Computed Tomography or cMRI) to EF \< 60% * Recent decrease in systemic ejection fraction confirmed by cardiac Echo, CT or MRI by \> 5% in the last 6 months or less. * Must be able to complete neurocognitive assessments on a handheld computer. Exclusion Criteria: * Diagnosed with Diabetes * Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022). * Previous therapy with Jardiance at \<4 weeks * Glomerular Filtration Rate \<20 * Pregnancy, breastfeeding, or planning to become pregnant in the coming year * History of liver disease - including non-alcoholic fatty liver disease (NAFLD) and cirrhosis * History of inborn error(s) of metabolism (including but is not exclusive of Glycogen storage disease type 1) * Glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease, * Gaucher disease, * Tay-Sachs disease, * Mucolipidosis IV, * Niemann-Pick disease, * Type A mitochondrial disease, * Metabolic disorders related to glucose metabolism

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Conditions

The condition(s) this trial relates to.

congenital heart disease heart failure

As listed by the trial registrant

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

Adult congenital heart disease Heart failure

Contacts and locations

Locations

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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