SGLT2 Inhibition With Empagliflozin for Fontan Circulatory Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, multicenter, randomized trial compares empagliflozin 10 mg once daily to placebo, in addition to standard care, for adults with Fontan circulatory failure. Participants are randomized 1:1 and followed for 12 weeks, with a mix of in-person and remote visits to assess clinical and patient-reported outcomes. The goal is to see if the medication can improve functional status and quality of life beyond current therapies. The study is double-blind, parallel-group, and uses a placebo control to rigorously evaluate benefits and safety. Enrollment targets 410 adults who meet the inclusion criteria after screening.

Why it matters

Who can join: the full rules

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

Where it's running

• St. Paul's Hospital
  Vancouver, British Columbia, Canada Recruiting
• University Health Network
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Nicole Cooke, CCRP
• Email: Nicole.cooke@unityhealth.to
• Phone: 416-864-6060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.