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Can a diabetes drug help hearts recover after valve surgery?

NCT ID NCT06171802

Disease control Sponsor: Rigshospitalet, Denmark 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 empagliflozin (Jardiance), a diabetes drug, can help the heart recover after aortic valve replacement. 206 patients took either the drug or a placebo for six months. The goal was to see if the drug reduces heart muscle thickness and improves symptoms.

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 way to improve heart healing after valve replacement, potentially reducing the risk of heart failure.
What could go wrong
This is a small, early-phase 4 trial with only 206 patients. The results may not be strong enough to change practice, and empagliflozin may not provide added benefit over standard care.

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

206 people

The number who actually took part.

Started

Feb 2024

Finished

May 2026

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: Severe symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days Exclusion Criteria: * Prior treatment with a SGLT2i * Left ventricular ejection fraction \< 45% * Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min * Hypersensitivity to empagliflozin or placebo tablet * Type I Diabetes * Patients who do not understand Danish or English * Women who are pregnant or are nursing or plan to become pregnant during trial

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

Aortic valve stenosis

Contacts and locations

Locations

  • University Hospital of Copenhagen, Rigshospitalet

    Copenhagen, 2100, Denmark

More trials for these conditions

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