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โ† Trials
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Randomized Trial of SGLT2i in Heart Transplant Recipients

RecruitingPhase 4Ages 18 Years - anyAllVA Office of Research and Development
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In plain words

What the trial is, and whether it could suit you

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, erythro

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Empagliflozin
  • Placebo
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Where

6 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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