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

Heart Failure Adult Congenital Heart Disease

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

Inclusion Criteria6

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 Criteria14

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