Health Trials

SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

ConditionCongenital Heart Disease
Trial statusNot yet recruiting
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

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

Treatments tested in this trial

  • Empagliflozin 10 mg
  • Placebo

Treatment groups

410 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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