RecruitingPhase 3NCT06955260

SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

A Randomized Trial of SGLT2 Inhibition With Empagliflozin in Adults With Fontan Circulatory Failure (EMPA-HEART 3 CardioLink-12)


Sponsor

Subodh Verma

Enrollment

410 participants

Start Date

May 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Empagliflozin 10 mg and Placebo for people with congenital heart disease. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 10 mg

Participants will take 10 mg of empagliflozin once daily

OTHERPlacebo

Participants will take 10 mg of placebo once daily


Locations(2)

St. Paul's Hospital

Vancouver, British Columbia, Canada

University Health Network

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06955260


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