Recruiting
Phase 3

Empagliflozin

Sponsor:

Subodh Verma

Code:

NCT06955260

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 10 mg

Placebo

Study Details

Brief 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.

Conditions

Congenital Heart Disease

Study ID

NCT06955260

Start date

May 29, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

410 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Empagliflozin

placebo comparator: Placebo

Interventions

Empagliflozin 10 mg

Participants will take 10 mg of empagliflozin once daily

Placebo

Participants will take 10 mg of placebo once daily

Primary outcome measure

  • Hierarchical endpoint [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Nicole Cooke, CCRP

416-864-6060Nicole.cooke@unityhealth.to

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Jasmine Grewal, MD

604-806-8804jagrewal@providencehealth.bc.ca

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

S. Lucy Roche, MD

416-340-5502lucy.roche@uhn.ca

Principal Investigator:

S. Lucy Roche, MD

More Information

Sponsor

Subodh Verma

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Fontan Circulatory Failure
  • Empagliflozin
  • Double-blind
  • randomized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Subodh Verma on 2026-09-02.