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Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
RECRUITINGPhase 4Sponsored by Anita Saraf
Actively Recruiting
PhasePhase 4
SponsorAnita Saraf
Started2024-09-17
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →
NCT06260059
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
Age: 18 Years+Healthy volunteers accepted
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-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease, * Gaucher disease, * Tay-Sachs disease, * Mucolipidosis IV, * Niemann-Pick disease, * Type A mitochondrial disease, * Metabolic disorders related to glucose metabolism
Conditions3
Adult Congenital Heart DiseaseHeart DiseaseHeart Failure
Locations3 sites
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Actively Recruiting
PhasePhase 4
SponsorAnita Saraf
Started2024-09-17
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →
NCT06260059