Randomized Trial of SGLT2i in Heart Transplant Recipients

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 Criteria:

1. Age 18 years or older
2. Heart transplant recipient, 3 months after transplant

Exclusion Criteria:

1. eGFR \<20 mL/min/1.73m2
2. Type 1 diabetes mellitus
3. HbA1C \>10%
4. Baseline UACR \<30 mg/g in patients without T2D
5. Known allergy or intolerance to SGLT2i
6. Active uncontrolled infection
7. Multiorgan transplant
8. SGLT2i treatment in the last 30 days
9. Pregnancy, breast-feeding or woman of child-bearing age not on birth control

Conditions4

Locations6 sites

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