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NCT06625073 · ClinicalTrials.gov registry record · Phase 4
Randomized Trial of SGLT2i in Heart Transplant Recipients
A Phase 4 study of Cardiovascular Disease and Kidney Disease, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
- 6
- Study locations
NCT06625073 is a Phase 4 study of Cardiovascular Disease and Kidney Disease that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 200 participants, below the 2,712-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (93% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT06625073, a Phase 4 study of Cardiovascular Disease and Kidney Disease, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
- 6
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,712-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (93% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
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.
NCT06625073 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Tennessee, Texas.
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.
What interventions are being tested in trial NCT06625073?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT06625073?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.