Actively Recruiting
Randomized Trial of SGLT2i in Heart Transplant Recipients
Led by VA Office of Research and Development · Updated on 2026-01-22
200
Participants Needed
6
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Trial of SGLT2i in Heart Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Heart transplant recipient, at least 3 months after transplant
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 20 mL/min/1.73m2
- Type 1 diabetes mellitus
- Hemoglobin A1c (HbA1C) greater than 10%
- Baseline urinary albumin-to-creatinine ratio (UACR) less than 30 mg/g in patients without type 2 diabetes
- Known allergy or intolerance to sodium-glucose cotransporter 2 inhibitors (SGLT2i)
- Active uncontrolled infection
- Multiorgan transplant recipients
- Treatment with SGLT2 inhibitors in the last 30 days
- Pregnancy, breastfeeding, or woman of child-bearing age not using birth control
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
Not Yet Recruiting
2
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
Not Yet Recruiting
3
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Not Yet Recruiting
4
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148-0001
Actively Recruiting
5
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249-0001
Not Yet Recruiting
6
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705-2254
Not Yet Recruiting
Research Team
H
Heather Hanson, AAS BS
CONTACT
J
Josef Stehlik, MD MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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