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Randomized Trial of SGLT2i in Heart Transplant Recipients
Sponsor: VA Office of Research and Development
Summary
Heart transplant (HTx) is an established therapy for advanced heart disease that restores quality of life and improves survival. However, due to preexisting comorbidities combined with the immunosuppressive therapies required after transplantation, HTx recipients remain at high risk for kidney, cardiovascular (CV), and metabolic disease. Large randomized clinical trials have recently shown that sodium-glucose cotransporter 2 inhibitors (SGLT2i) have potent kidney protective and CV benefits in many populations of patients with chronic kidney disease (CKD), CV disease and/or diabetes. SGLT2i have not been studied prospectively in HTx recipients, which represents a barrier to their use in this population. In this multicenter randomized controlled trial in Veterans with HTx, investigators will evaluate the potential benefits of empagliflozin on kidney function, cardiometabolic risk, erythropoiesis, and functional status. A total of 200 Veterans will be randomly assigned to receive either empagliflozin 10 mg daily or a matching placebo for 12 months.
Official title: Randomized Trial of Sodium-glucose Cotransporter 2 Inhibition in Heart Transplant Recipients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-01-20
Completion Date
2030-02-28
Last Updated
2026-01-22
Healthy Volunteers
No
Interventions
Empagliflozin
A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.
Placebo
A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.
Locations (6)
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States