drugset / Trial / NCT06955260

SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

NCT06955260

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-05
Primary completion
2027-12
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Empagliflozin Small molecule 10 mg