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Could a diabetes pill boost heart health in fontan patients?

NCT ID NCT07482943

Disease control Sponsor: The University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests whether dapagliflozin, a drug already approved for diabetes and heart failure, can improve exercise ability and heart function in people who have had the Fontan procedure. About 30 participants aged 12 and older will take the drug daily for 3 months. The goal is to see if it helps them use oxygen more efficiently during exercise, which could mean better daily life and fewer hospital visits.

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 30 people

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

Started

Jul 2026

Expected to finish

Jul 2028

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

12 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: * Patients with a functional single ventricle and who have undergone Fontan procedure * Adolescents aged ≥ 12 years with body weight ≥30kg and adults Exclusion Criteria: * Planned cardiac and/or non-cardiac surgery in 3 months * Arrhythmias requiring change in therapy in recent 6 months * Intervention procedure within 6 months prior to enrollment * Documented structural abnormalities of the Fontan circulation * Chronic kidney disease stages 4 to 5 * Inability to perform cardiopulmonary test * Recent use of SGLT2 inhibitors within 6 months * Known hypersensitivity to SGLT2 inhibitors * History of diabetic ketoacidosis * Recent symptomatic hypoglycaemia within 6 months * Insulin dependent diabetes mellitus * History of perineum infection * Recent urinary tract infection within 6 months * Recent genital infection within 6 months * Other known contraindications to SGLT2 inhibitor * Pregnancy or breast feeding

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder congenital heart disease heart failure

As listed by the trial registrant

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

Cardiovascular diseases Dapagliflozin FONTAN Heart failure Sodium-glucose cotransporter-2 inhibitors

How to take part

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

  1. The places running it

    2 sites. 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

  • Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Queen Mary Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

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