SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

ConditionCongenital Heart Disease

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorSubodh Verma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Empagliflozin 10 mg
Drug
Participants will take 10 mg of empagliflozin once daily
Placebo
Other intervention
Participants will take 10 mg of placebo once daily

Treatment groups

410 Participants

are divided into 2 treatment groups

Group A: EmpagliflozinActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

Fontan revision surgery

Time to Fontan revision surgery: atrioventricular valve replacement or repair, aortic valve replacement, Fontan conduit replacement (days)

Time frame

Week 12

Fontan conversion surgery

Time to Fontan conversion surgery from right atrial-pulmonary artery to lateral tunnel or extracardiac (days)

Time frame

Week 12

Change in cardiopulmonary exercise testing (CPET) variables if collected for clinical reasons

Blood pressure (BP) at baseline and peak exercise (mmHg)

Time frame

Week 12

Change in cardiopulmonary exercise testing (CPET) variables if collected for clinical reasons

Heart rate at baseline and peak exercise (BPM)

Time frame

Week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Subodh Verma

Lead sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Sponsor institution

Boehringer Ingelheim

Collaborator

Applied Health Research Centre

Collaborator

Source ClinicalTrials.gov

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