SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure (NCT06955260) | Clinical Trial Compass
Not Yet RecruitingPhase 3
SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure
Canada410 participantsStarted 2025-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.