Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Adult Congenital Heart Disease, Heart Failure
In brief
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).
Key facts
- Study ID
- NCT06260059
- Run by
- Anita Saraf
- People needed
- 40
- Starts
- 2024-09-17
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-10-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Magee Women's Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
- Presbyterian Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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