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.
EMPA-HEART 3 CardioLink-12 is a global, multicentre, randomized, double-blinded, placebo-controlled, parallel group trial of empagliflozin vs. placebo in addition to standard of care therapy in adults with Fontan Circulatory Failure (FCF). A total of 410 individuals who provide written informed consent and meet the inclusion criteria following screening will be randomized (1:1) to receive either empagliflozin 10 mg once daily or matching placebo. During the 12-week follow-up, there will be four in-person and three telephone/virtual assessment visits. The primary goal of this investigation is to determine whether 12 weeks of therapy with the sodium-glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin, will improve clinical and participant-reported outcome measures in adults with FCF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
410
Participants will take 10 mg of empagliflozin once daily
Participants will take 10 mg of placebo once daily
University Health Network
Toronto, Ontario, Canada
Hierarchical endpoint
Primary hierarchical composite outcome will be analyzed using a win ratio based on the Finkelstein-Schoenfeld test. * All cause death (no. of participants) * Listing for heart transplantation or initiation of mechanical circulatory support (no. of participants) * Sustained ventricular tachycardia or aborted sudden cardiac death (no. of participants) * Hospital admission for management of FCF defined by any of the following: * Admission for intravenous diuretics (no. of participants) * Admission for intravenous inotropes (no. of participants) * Admission for ascites drainage (no. of participants) * Admission for management of new or worsening ascites of clinical significance (no. of participants) * Admission for management of arrhythmia (no. of participants) * Admission for management of lymphatic dysfunction (no. of participants) * ≥5 points change in the KCCQ-Clinical Summary Score (KCCQ-CSS) from baseline to Week 12 * Change in 6-minute walk distance f
Time frame: Week 12
All cause death
All cause death (no. of participants)
Time frame: Week 12
Listing for heart transplantation or initiation of mechanical circulatory support
Listing for heart transplantation or initiation of mechanical circulatory support (no. of participants)
Time frame: Week 12
Sustained ventricular tachycardia or aborted sudden cardiac death
Sustained ventricular tachycardia or aborted sudden cardiac death (no. of participants)
Time frame: Week 12
Hospital admission for management of FCF
Hospital admission for management of FCF (in number of participants) as defined by any of the following: * Admission for intravenous diuretics (no. of participants) * Admission for intravenous inotropes (no. of participants) * Admission for ascites drainage (no. of participants) * Admission for management of new or worsening ascites of clinical significance (no. of participants) * Admission for management of arrhythmia (no. of participants) * Admission for management of lymphatic dysfunction (no. of participants)
Time frame: Week 12
Change in KCCQ-Clinical Summary Score
≥5 points change in the KCCQ-Clinical Summary Score (KCCQ-CSS) from baseline (no. of participants)
Time frame: Week 12
Change in 6-minute walk test
Change in 6-minute walk distance (in meters)
Time frame: Week 12
Time to severe FCF
Time to severe FCF, defined as the first occurrence of any of the following: * Death (days) * Placement on heart or combined heart and liver transplantation list (days) * Initiation of palliative care because the individual is not a heart transplant candidate (days) * Fontan take down surgery (days)
Time frame: Week 12
Change in FCF status
Investigator-reported global change in FCF status (days)
Time frame: Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.