RecruitingPhase 4NCT06260059

Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease

Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2i) in Adult Patients With Congenital Heart Disease


Sponsor

Anita Saraf

Enrollment

40 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a medication called an SGLT2 inhibitor (the brand name Jardiance is mentioned) in adults with congenital heart disease — heart defects present from birth — who are experiencing a decline in their heart's pumping function. SGLT2 inhibitors have shown heart benefits in other populations, and this trial tests whether they help in congenital heart disease. **You may be eligible if...** - You are 18 or older - You have congenital heart disease (a heart condition you were born with) - Your heart pumping function has recently declined (ejection fraction below 60% and dropped more than 5% in the last 6 months) - Your heart defect is of moderate or complex structural type - You can complete computer-based mental assessments **You may NOT be eligible if...** - You have been diagnosed with diabetes - You have a contraindication to Jardiance or related heart failure medications - Your kidney function is very poor (GFR below 20) - You are pregnant, breastfeeding, or planning pregnancy within the next year - You have liver disease, or certain rare metabolic or enzyme disorders Talk to your doctor to see if this trial is right for you.

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

Patient will be given 10 mg of Empagliflozin if randomized to the drug arm or will receive placebo drug for 1 year

DRUGPlacebo

To patients randomized to the placebo group, a placebo pill will be given


Locations(3)

Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06260059


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