NCT06260059Active, not recruitingPhase 4
Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 2 Jan 2024
- Start date
- 17 Sept 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Anita Saraf
- Diseases
- Heart failure
- NCT number
- NCT06260059
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 17 Sept 2024 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous therapy with Jardiance at \<4 weeks
Other illness
- Diagnosed with Diabetes
- Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022).
- 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)
- Gaucher disease,
- Tay-Sachs disease,
- Niemann-Pick disease,
- Type A mitochondrial disease,
Lab values
- Glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease,
- Metabolic disorders related to glucose metabolism
Other
- Glomerular Filtration Rate \<20
- Pregnancy, breastfeeding, or planning to become pregnant in the coming year
- Mucolipidosis IV,
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Magee - Women's Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Presbyterian Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.