← Back to Clinical Trials
Recruiting Phase 4 NCT06260059

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

Trial Parameters

Condition Adult Congenital Heart Disease
Sponsor Anita Saraf
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-17
Completion 2026-12-31
Interventions
Empagliflozin 10 MGPlacebo

Brief 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 Criteria

Inclusion Criteria: * Diagnoses of Congenital Heart Disease * Age 18+ * ACHD level of structural complexity II or III * Recent (\<6 months) decrease in systemic Ejection Fraction (confirmed by cardiac Echocardiogram, Computed Tomography or cMRI) to EF \< 60% * Recent decrease in systemic ejection fraction confirmed by cardiac Echo, CT or MRI by \> 5% in the last 6 months or less. * Must be able to complete neurocognitive assessments on a handheld computer. Exclusion Criteria: * Diagnosed with Diabetes * Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022). * Previous therapy with Jardiance at \<4 weeks * Glomerular Filtration Rate \<20 * Pregnancy, breastfeeding, or planning to become pregnant in the coming year * History of liver disease - including non-alcoholic fatty liver disease (NAFLD) and cirrhosis * History of inborn error(s) of metabolism (including but is not exclusive of Glycogen storage disease type 1) * Glucose-galac

Related Trials