Actively Recruiting
Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2i) in Adult Patients With Congenital Heart Disease
Led by Anita Saraf · Updated on 2025-10-06
40
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
Sponsors
A
Anita Saraf
Lead Sponsor
T
The Pittsburgh Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Empagliflozin (Jardiance), a drug approved for non-congenital heart failure, in adults with congenital heart disease (ACHD) who experience heart muscle dysfunction, arrhythmia, and heart failure symptoms. The study aims to see if Empagliflozin can improve heart function, reduce inflammation, and enhance neurocognitive outcomes in these patients. This is a phase 4 clinical trial focusing on the prevention and treatment of heart complications in ACHD patients. Participants will be randomly assigned to receive either Empagliflozin 10 mg once daily or a placebo for one year. Both the patients and researchers will be unaware of group assignments to ensure unbiased results. The study will measure changes in heart function, myocardial characteristics using MRI and echocardiogram, exercise capacity, hospitalizations, and death rates over the course of treatment. Throughout the study, participants will undergo various assessments including cardiac imaging, exercise tests, blood tests for inflammatory markers, and neuropsychological evaluations using handheld devices. Researchers will also track hospitalizations and monitor overall health outcomes. The study will last for one year, with primary outcomes measured at the end of this period to evaluate the potential benefits and safety of Empagliflozin in ACHD patients.
CONDITIONS
Brief Title
Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with congenital heart disease
- Age 18 years or older
- ACHD level of structural complexity II or III
- Recent decrease in systemic ejection fraction to below 60%
- Decrease in ejection fraction by more than 5% within the last 6 months
- Able to complete neurocognitive tests on a handheld computer
You will not qualify if you...
- Diagnosed with diabetes
- Contraindicated for Jardiance, Entresto, or any heart failure medication per 2022 guidelines
- Previous Jardiance therapy within 4 weeks
- Glomerular filtration rate below 20
- Pregnant, breastfeeding, or planning pregnancy within one year
- History of liver disease including non-alcoholic fatty liver disease and cirrhosis
- History of inborn errors of metabolism such as glycogen storage disease type 1
- Conditions including glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease, Gaucher disease, Tay-Sachs disease, Mucolipidosis IV, Niemann-Pick disease, type A mitochondrial disease, or metabolic disorders related to glucose metabolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 1 year
Participants receive once-a-day oral Empagliflozin 10 mg or placebo for 1 year to evaluate its effects on heart function and symptoms.
Regular visits throughout the year for medication administration and monitoring
Trial Site Locations
Total: 3 locations
1
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
2
Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
3
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
A
Anita Saraf, MD, PhD
M
Morgan Hindes
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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