Actively Recruiting
Study of Empagliflozin Jardiance for Treating Adults with Congenital Heart Disease and Heart Failure
Led by Anita Saraf · Updated on 2025-10-06
40
Participants Needed
3
Research Sites
21 weeks
Total Duration
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
Research Team
A
Anita Saraf, MD, PhD
M
Morgan Hindes
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