NCT06955260RecruitingPhase 3
SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure
A Randomized Trial of SGLT2 Inhibition With Empagliflozin in Adults With Fontan Circulatory Failure (EMPA-HEART 3 CardioLink-12)
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- First submitted
- 15 Mar 2025
- Start date
- 29 May 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Subodh Verma
- NCT number
- NCT06955260
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 410
- From 29 May 2026 to the primary completion date, Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.