SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

Launched by SUBODH VERMA · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called empagliflozin to see if it can help improve the quality of life for adults with Fontan Circulatory Failure (FCF), a condition that affects people born with a heart defect where only one ventricle works properly. After undergoing a Fontan operation, many individuals may face challenges as they grow older, with their single ventricle struggling to pump enough blood and oxygen for everyday activities. Currently, a heart transplant is the only treatment option available for those with FCF, so researchers are hopeful that empagliflozin could provide a new way to help manage this condition.

To participate in this trial, you must be at least 18 years old and diagnosed with FCF, meaning you experience limitations in daily activities due to your heart condition. However, there are certain criteria that could exclude you from participating, such as having recently changed medications or certain health issues. If eligible, participants can expect to take the medication and undergo regular check-ups to monitor their health. This trial is not yet recruiting, but it represents an important step towards finding new treatment options for those living with FCF.

Gender

ALL

Eligibility criteria

• 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