Empagliflozin to protect kidney and heart health after heart transplant
Randomized Trial of Sodium-glucose Cotransporter 2 Inhibition in Heart Transplant Recipients
This trial will test whether empagliflozin can protect kidney and heart health and improve metabolic and functional outcomes in Veterans who have had a heart transplant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 6 sites (Palo Alto, California and 5 other locations) |
| Trial ID | NCT06625073 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled, multicenter Phase 4 trial will enroll 200 Veterans at least 3 months after heart transplant and assign them to empagliflozin or matching placebo. Participants will be followed with regular clinic visits and laboratory testing to track kidney function, cardiometabolic measures, markers of erythropoiesis, and functional status. Key exclusions include severe kidney dysfunction (eGFR <20 mL/min/1.73 m2), type 1 diabetes, very high HbA1c (>10%), recent SGLT2i use, multiorgan transplant, active uncontrolled infection, and pregnancy or breastfeeding without contraception. The aim is to see if empagliflozin can slow kidney decline, reduce cardiovascular complications, and improve metabolic and functional outcomes after heart transplant.
Who should consider this trial
Good fit: Ideal candidates are adult Veterans at least 3 months post-heart transplant with adequate kidney function (not eGFR <20), without type 1 diabetes, and who meet other safety criteria.
Not a fit: Patients with very low kidney function (eGFR <20 mL/min/1.73 m2), type 1 diabetes, multiorgan transplants, recent SGLT2i use, active uncontrolled infection, or pregnant/breastfeeding women not using birth control are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, empagliflozin could slow kidney decline, reduce cardiovascular complications, improve metabolic health, and enhance quality of life after heart transplant.
How similar studies have performed: Large randomized trials in people with chronic kidney disease, cardiovascular disease, or diabetes have demonstrated kidney and cardiovascular benefits of SGLT2 inhibitors, but these drugs have not been tested prospectively in heart transplant recipients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California and 5 other locations
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (Not_yet_recruiting)
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States (Not_yet_recruiting)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (Not_yet_recruiting)
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (Recruiting)
- Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States (Not_yet_recruiting)
- William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Josef Stehlik, MD MPH — VA Salt Lake City Health Care System, Salt Lake City, UT
- Study coordinator: Heather Hanson, AAS BS
- Email: Heather.Hanson@va.gov
- Phone: (801) 582-1565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.