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Heart drug hope: diabetes meds may help adults born with heart defects

NCT ID NCT06932081

Knowledge-focused Sponsor: Leiden University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This international registry is tracking 400 adults with congenital heart disease who are taking SGLT2 inhibitors, a type of diabetes medication that also benefits the heart. Researchers want to see how these drugs are being prescribed, how well they are tolerated, and whether they improve heart failure outcomes. The study is purely observational, meaning it collects real-world data without assigning treatments.

What this could mean

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

Active substance
SGLT2 inhibitors (a class of diabetes drugs that help the heart and kidneys)
What this could lead to
If successful, this registry could show that SGLT2 inhibitors are safe and helpful for adults with congenital heart disease, potentially leading to better heart failure management.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by other factors, and the study is relatively small (400 participants).

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.

Participants

About 400 people

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

Started

Jan 2023

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.

Who is studied

All adult patients (≥ 18 years) with congenital heart disease who have been treated with an SGLT2i are eligible for inclusion in the registry.

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: * Congenital heart defect. * Age ≥ 18 years. * Initiated on treatment with an SGLT2i. Exclusion Criteria: \- No consent for data collection.

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Conditions

The condition(s) this trial relates to.

congenital heart disease congenitally corrected transposition of the great arteries heart failure tetralogy of fallot transposition of the great arteries univentricular heart

As listed by the trial registrant

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

Adult congenital heart disease Congenital heart disease Congenitally corrected transposition of the great arteries FONTAN Single-ventricle Systemic right ventricle Tetralogy of fallot (TOF) Transposition of the great arteries

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 in 5 countries. 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

  • Amsterdam University Medical Center

    RECRUITING

    Amsterdam, Netherlands

  • Barts Heart Centre

    RECRUITING

    London, United Kingdom

  • Golden Jubilee University National Hospital

    RECRUITING

    Glasgow, United Kingdom

  • Heart Center Duisburg (Evangelical Hospital Niederrhein)

    RECRUITING

    Duisburg, Germany

  • Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Leiden University Medical Center (LUMC)

    RECRUITING

    Leiden, South Holland, 2333ZA, Netherlands

  • Mount Sinai Fuster Heart Hospital

    RECRUITING

    New York, New York, 10029, United States

  • University Hospital of Wales

    RECRUITING

    Cardiff, United Kingdom

  • University Medical Center Utrecht

    RECRUITING

    Utrecht, Netherlands

  • Zan Mitrev Clinic

    RECRUITING

    Skopje, North Macedonia

More trials for these conditions

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