NCT06625073 Randomized Trial of SGLT2i in Heart Transplant Recipients
| NCT ID | NCT06625073 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | VA Office of Research and Development |
| Condition | Heart Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2026-01-20 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Josef Stehlik, MD MPH
PRINCIPAL INVESTIGATOR
VA Salt Lake City Health Care System, Salt Lake City, UT
Frequently Asked Questions
Who can join the NCT06625073 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06625073 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06625073 currently recruiting?
Yes, NCT06625073 is actively recruiting participants. Contact the research team at Heather.Hanson@va.gov for enrollment information.
Where is the NCT06625073 trial being conducted?
This trial is being conducted at Palo Alto, United States, Nashville, United States, Houston, United States, Salt Lake City, United States and 2 additional locations.
Who is sponsoring the NCT06625073 clinical trial?
NCT06625073 is sponsored by VA Office of Research and Development. The principal investigator is Josef Stehlik, MD MPH at VA Salt Lake City Health Care System, Salt Lake City, UT. The trial plans to enroll 200 participants.