Can a diabetes drug ease the strain of a failing single-ventricle heart?

NCT ID NCT06955260

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Some people are born with only one working lower heart chamber, a condition often managed with a Fontan operation. Over time, that single ventricle can weaken, leading to Fontan circulatory failure, where the heart struggles to pump enough oxygen-rich blood. This trial tests whether empagliflozin, a drug used for diabetes and heart failure, can improve quality of life and reduce serious events in adults with this condition. Participants take either empagliflozin or a placebo daily, and researchers track outcomes like hospital admissions, heart function, and daily activity capacity.

What this could mean

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

Active substance
empagliflozin 10 mg taken once daily
What this could lead to
If it works, empagliflozin could become the first medication to ease symptoms and improve daily life for people with Fontan circulatory failure, potentially delaying the need for a heart transplant.
What could go wrong
This is a large phase 3 trial, but empagliflozin may not outperform placebo. Possible side effects include dehydration, urinary tract infections, and other risks tied to SGLT2 inhibitors.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 410 people

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

Started

May 2026

Expected to finish

Mar 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

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: * Adults (≥18 years of age) with FCF, defined by dysfunction of the Fontan physiology that causes limitation to the individual's ability to carry out daily life activities, on standard of care therapy Exclusion Criteria: * Diuretic initiation or dose change ≤2 weeks prior to enrollment On a SGLT2 inhibitor currently or within 12-weeks prior to enrollment in the trial * Allergic to or has a known intolerance to any of the ingredients in empagliflozin or other SGLT2 inhibitors * Pregnant or planning a pregnancy during the duration of the trial or breast feeding * Living with type 1 diabetes mellitus * Has an unresolved acute illness (e.g., acute appendicitis, COVID-19, gastroenteritis) * History of ketoacidosis * Has an estimated glomerular filtration rate (eGFR) that is \<30 mL/min/1.73 m2 Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2-fold upper limit of normal (ULN) at screening * Has a baseline systolic BP that is \<80 mmHg or ≥200 mmHg * Planned hospital intervention during trial period for management of FCF defined as one of the following: * Admission for intravenous diuretics * Admission for intravenous inotropes * Admission for ascites drainage * Admission for new or worsening ascites of clinical significance * Admission for management of arrhythmia * Admission for management of lymphatic dysfunction * Admission for interventional cardiological or cardiac surgical procedure within 30-days prior to screening, or consideration for any cardiac surgical or interventional cardiological procedure during trial participation * Admission for cardiac resynchronization therapy within 90-days prior to screening, or consideration of cardiac resynchronization therapy during trial participation * Is unable to provide written informed consent, complete the trial or comply with the requirements of the trial protocol * Participation in other interventional studies within 30-days of the screening visit that could influence any of the trial outcomes (exclusive of observational registries) * Received intravenous diuretic within the previous 14-days * On a heart transplant waiting list * Current or imminent hospitalization for management of FCF

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Congenital heart disease are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • St. Paul's Hospital

    RECRUITING

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

More trials for these conditions

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