Home › Cardiovascular Disease › NCT06625073
Randomized Trial of SGLT2i in Heart Transplant Recipients
Randomized Trial of Sodium-glucose Cotransporter 2 Inhibition in Heart Transplant Recipients
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Empagliflozin (drug)
- Placebo (drug)
Sponsor: VA Office of Research and Development · Participants: 200 · Started: Jan 20, 2026
Contact the study team
- Heather Hanson, AAS BS · Phone: (801) 582-1565
- Josef Stehlik, MD MPH · Phone: (801) 582-1565
Official record on ClinicalTrials.gov — NCT06625073
Locations in the U.S.
| California | VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto (Not yet recruiting) |
| Tennessee | Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville (Not yet recruiting) |
| Texas | Michael E. DeBakey VA Medical Center, Houston, TX, Houston (Not yet recruiting) |
| Utah | VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City |
| Virginia | Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond (Not yet recruiting) |
| Wisconsin | William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.