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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

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

Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Anita Saraf, MD, PhDsaraf@pitt.edu
Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Anita Saraf, MD, PhDsaraf@pitt.edu
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Anita Saraf, MD,PhDsaraf@pitt.edu

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