Using Empagliflozin to treat heart failure in adults with congenital heart disease
Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2i) in Adult Patients With Congenital Heart Disease
This study is testing if the heart medication Empagliflozin can help adults with congenital heart disease feel better and improve their heart function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 3 sites (Pittsburgh, Pennsylvania and 2 other locations) |
| Trial ID | NCT06260059 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Empagliflozin, a medication typically used for heart failure, in adult patients with congenital heart disease (ACHD). It aims to assess how this drug can improve heart function and reduce symptoms like shortness of breath in patients who have experienced a decline in their heart's ejection fraction. The study will involve administering either Empagliflozin or a placebo to eligible participants and monitoring their heart health over time. The goal is to determine if this treatment can prevent further complications associated with ACHD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with congenital heart disease and a recent decrease in heart function.
Not a fit: Patients with diabetes or contraindications to the medication will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with congenital heart disease.
How similar studies have performed: Preliminary evaluations of Empagliflozin in similar patient populations have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburgh, Pennsylvania and 2 other locations
- Magee Women's Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Presbyterian Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Anita Saraf, MD, PhD — Assistant Professor
- Study coordinator: Anita Saraf, MD, PhD
- Email: sarafap@upmc.edu
- Phone: 4128648661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.