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
141 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
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).
CONDITIONS
Official 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 (within less than 6 months) in systemic ejection fraction to below 60%
- Recent decrease in systemic ejection fraction by more than 5% in the past 6 months or less, confirmed by cardiac Echo, CT, or MRI
- Able to complete neurocognitive assessments using a handheld computer
You will not qualify if you...
- Diagnosed with diabetes
- Contraindication to Jardiance, Entresto, or any heart failure medication as per guidelines
- Previous therapy with Jardiance within the last 4 weeks
- Glomerular filtration rate below 20
- Pregnant, breastfeeding, or planning to become pregnant within the coming year
- History of liver disease including non-alcoholic fatty liver disease or cirrhosis
- History of inherited metabolic disorders such as 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, or other metabolic disorders related to glucose metabolism
AI-Screening
AI-Powered Screening
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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
CONTACT
M
Morgan Hindes
CONTACT
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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