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SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

NCT06955260 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2025-05-02

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease

Interventions

DRUG

Empagliflozin 10 mg

Participants will take 10 mg of empagliflozin once daily

OTHER

Placebo

Participants will take 10 mg of placebo once daily

Sponsors & Collaborators

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Applied Health Research Centre

    collaborator OTHER

  • Subodh Verma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2027-12-31
Completion
2028-03-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955260 on ClinicalTrials.gov