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NCT06625073
Randomized Trial of SGLT2i in Heart Transplant Recipients
Phase 4 trial testing Empagliflozin in Heart Transplant in 200 participants. Currently enrolling.
31 August 2029
Quick facts
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 20 January 2026 |
| Primary completion | 31 August 2029 |
| Estimated completion | 28 February 2030 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Empagliflozin (empagliflozin) — full drug profile →
- Placebo
Conditions studied
- Heart Transplant — all drugs for Heart Transplant →
- Cardiovascular Disease — all drugs for Cardiovascular Disease →
- Kidney Disease — all drugs for Kidney Disease →
Sponsor
VA Office of Research and Development — full company profile →
Who can join
18 and older, any sex, with Heart Transplant or Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Expanding the scope of SGLT inhibitors in underrepresented cardiac populations: from pathophysiology to clinical evidence.
Padda B, Kelleher JT, Muroke V, Sridhar VS, et al · · 2026 · PMID 42181622 · DOI 10.3389/fcvm.2026.1809193
Verify or expand the search:
- PubMed search for NCT06625073
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Empagliflozin
Trials testing the same drug.
- NCT07060417 — Vascular Effects of SGLT2i in Non-diabetic CKD · Phase 2 · not yet recruiting
- NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease · Phase 3 · recruiting
- NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
- NCT07180745 — Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease · Phase 4 · not yet recruiting
- NCT07331389 — A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin · Phase 1 · recruiting
Other recruiting trials for Heart Transplant
Currently open trials in the same condition.
- NCT05025774 — Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise · recruiting
- NCT06478017 — Belatacept in Heart Transplantation · Phase 2 · recruiting
- NCT06426173 — Effect of Resistance Training in Patients on the Waiting List for Heart Transplant · NA · recruiting
- NCT07125703 — Observational Study With Additional Procedures: Metabolomic and Ultrastructural Findings of Allograft in Heart Transplan · active not recruiting
- NCT05933083 — MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation · NA · recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
- NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
- NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
- NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
- NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
- NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06625073 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
- Last refreshed: 22 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06625073.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing