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Randomized Trial of SGLT2i in Heart Transplant Recipients
NCT06625073 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Empagliflozin
Study Locations (6)
California
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
Tennessee
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston
Utah
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City
Virginia
- Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond
Wisconsin
- William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-01-20 |
| Est. Completion | 2030-02-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06625073
The ClinicalTrials.gov registry entry for NCT06625073 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06625073 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Tennessee, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06625073 about?
NCT06625073 is a clinical study titled "Randomized Trial of SGLT2i in Heart Transplant Recipients". 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, card...
What is the current status of trial NCT06625073?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2026-01-20. Estimated completion is 2030-02-28.
What conditions does trial NCT06625073 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Kidney Disease, Heart Transplant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06625073?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06625073?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06625073 being conducted?
This trial has 6 study locations across California, Tennessee, Texas, Utah, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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