Tests empagliflozin in adults with Fontan circulatory failure
Tests empagliflozin against placebo in adults with single-ventricle heart failure after Fontan surgery.
Plain-language title generated from the registry record
Registry title: SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure
Key facts
- Where
- Toronto and Vancouver, CanadaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Fontan circulatory failure, a heart condition after a Fontan operation, who are limited in daily activities despite standard treatment. It tests empagliflozin against placebo.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Fontan circulatory failure: the Fontan circulation works poorly and limits daily life activities, while on standard of care therapy
- Earlier treatment
- Must be on standard of care therapy. Cannot have taken an SGLT2 inhibitor now or within 12 weeks before enrolment.
Main reasons for not taking part
- On a SGLT2 inhibitor now or within 12 weeks before enrolment
- Pregnant, planning a pregnancy, or breast feeding
- Type 1 diabetes or a history of ketoacidosis
- eGFR below 30 mL/min/1.73 m2
- On a heart transplant waiting list
Read by machine on 12 November 2026.
Where in Canada
- University Health NetworkToronto, CanadaContact: S. Lucy Roche, MDTaking people
- St. Paul's HospitalVancouver, CanadaContact: Jasmine Grewal, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Subodh Verma
- Trial code
- NCT06955260
- Record updated
- 2 September 2026
- Original description
Some people are born with a birth defect where they only have one functioning ventricle (lower chamber) in their heart. This condition can be initially managed with a Fontan operation, but there is a risk of developing Fontan Circulatory Failure (FCF) later in life. FCF occurs when the single working heart ventricle is no longer strong enough to pump blood throughout the body. This also means the heart has difficulty supplying oxygen to keep up with the needs of the body. As a result, individuals living with FCF may have some challenges carrying out day to day activities. A heart transplant is currently the only therapeutic option for individuals living with FCF. The investigators are conducting this trial to determine whether a medication called empagliflozin can help these people have a better quality of life.Read full original descriptionShow less
A Randomized Trial of SGLT2 Inhibition With Empagliflozin in Adults With Fontan Circulatory Failure (EMPA-HEART 3 CardioLink-12)
Some people are born with a birth defect where they only have one functioning ventricle (lower chamber) in their heart. This condition can be initially managed with a Fontan operation, but there is a risk of developing Fontan Circulatory Failure (FCF) later in life. FCF occurs when the single working heart ventricle is no longer strong enough to pump blood throughout the body. This also means the heart has difficulty supplying oxygen to keep up with the needs of the body. As a result, individuals living with FCF may have some challenges carrying out day to day activities. A heart transplant is currently the only therapeutic option for individuals living with FCF. The investigators are conducting this trial to determine whether a medication called empagliflozin can help these people have a better quality of life.
Inclusion: 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: 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; 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; Received intravenous diuretic within the previous 14-days; Allergic to or has a known intolerance to any of the ingredients in empagliflozin or other SGLT2 inhibitors; Living with type 1 diabetes mellitus; Has an unresolved acute illness (e.g., acute appendicitis, COVID-19, gastroenteritis); History of ketoacidosis; Admission for management of arrhythmia; On a heart transplant waiting list; 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; Pregnant or planning a pregnancy during the duration of the trial or breast feeding; 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 lymphatic dysfunction; 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); Current or imminent hospitalization for management of FCF.