Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
Recruiting · NCT06260059 · Interventional (participants receive a specific treatment) · Lead sponsor: Anita Saraf
View the official record on ClinicalTrials.gov →Interventions studied
Empagliflozin 10 MGPlacebo
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed across 1 US state.
- Magee Women's Hospital - Pittsburgh, Pennsylvania, United States
- Presbyterian Hospital - Pittsburgh, Pennsylvania, United States
- Children's Hospital of Pittsburgh - Pittsburgh, Pennsylvania, United States