Randomized Trial of SGLT2i in Heart Transplant Recipients
Randomized Trial of Sodium-glucose Cotransporter 2 Inhibition in Heart Transplant Recipients
VA Office of Research and Development
200 participants
Jan 20, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Age 18 years or older
- Heart transplant recipient, 3 months after transplant
Exclusion Criteria9
- eGFR <20 mL/min/1.73m2
- Type 1 diabetes mellitus
- HbA1C >10%
- Baseline UACR <30 mg/g in patients without T2D
- Known allergy or intolerance to SGLT2i
- Active uncontrolled infection
- Multiorgan transplant
- SGLT2i treatment in the last 30 days
- Pregnancy, breast-feeding or woman of child-bearing age not on birth control
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06625073