SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

Sponsor
Subodh Verma
Study ID
NCT06955260
Phase
PHASE3
Status
Recruiting
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Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 mg — DRUG
    Participants will take 10 mg of empagliflozin once daily
  • Placebo — OTHER
    Participants will take 10 mg of placebo once daily

Study Details

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.

Key Dates

First listed
May 2, 2025
Start date
May 29, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empagliflozin
  • Placebo Comparator: Placebo

Primary Outcome Measure

Hierarchical endpoint [ Time Frame: Week 12 ]

Central Contacts

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