Randomized Trial of SGLT2i in Heart Transplant Recipients
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Heart Transplant, Cardiovascular Disease, Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT06625073
- Run by
- VA Office of Research and Development
- People needed
- 200
- Starts
- 2026-01-20
- Expected to finish
- 2030-02-28
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older
- Heart transplant recipient, 3 months after transplant
You may not qualify if…
- 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
Where it is running
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (enrolling)
- 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
- Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States
- William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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