Randomized Trial of SGLT2i in Heart Transplant Recipients (NCT06625073)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (10 items).
Location: VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah
- Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia
- William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.