Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2i) in Adult Patients With Congenital Heart Disease
Anita Saraf
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).
Description
As CHD adolescents transition to adulthood, it is becoming evident that in addition to their structural cardiac abnormalities, they also have an intrinsic disease of the heart muscle which manifests as abnormal heart rhythm (arrhythmia) and decreased function (heart failure). The lifesaving cardiac surgeries during childhood can also contribute to this dysfunction (cardiomyopathy). Hence, patients with CHD require multiple interventions and close clinical follow-up throughout their life. Currently, there are over 2.5 million CHD patients in the U.S. alone, and an additional 40,000 babies are…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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-di…
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 HospitalPittsburgh, Pennsylvania
- Presbyterian HospitalPittsburgh, Pennsylvania
- Children's Hospital of PittsburghPittsburgh, Pennsylvania