Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2i) in Adult Patients With Congenital Heart Disease
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Pennsylvania
Children's Hospital of Pittsburgh
RECRUITING
Pittsburgh
Magee Women's Hospital
RECRUITING
Pittsburgh
Presbyterian Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Anita Saraf, MD, PhD
sarafap@upmc.edu
4128648661
Backup
Morgan Hindes
mhindes@chp.edu
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 40
Treatments
Experimental: Empagliflozin 10 MG
Empagliflozin 10 mg daily will be administered for 1 year. The patient and the PI will be blinded (unaware) of the group they are assigned to.
Placebo_comparator: Placebo
Placebo for 1 year
Related Therapeutic Areas
Sponsors
Leads: Anita Saraf
Collaborators: The Pittsburgh Foundation