Recruiting

Empagliflozin

Sponsor:

VA Office of Research and Development

Code:

NCT06625073

Conditions

Heart Transplant

Cardiovascular Disease

Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin

Placebo

Study Details

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.

Conditions

Heart Transplant

Cardiovascular Disease

Kidney Disease

Study ID

NCT06625073

Start date

Jan 20, 2026

Status verified date

Jan, 2026

Completion date

Feb 28, 2030

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empagliflozin

A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.

placebo comparator: Placebo

A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.

Interventions

Empagliflozin

A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.

Placebo

A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.

Primary outcome measure

  • Urinary albumin-to-creatinine ratio (UACR) [ Time Frame: 12 months ]
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Heather Hanson, AAS BS

(801) 582-1565Heather.Hanson@va.gov

Josef Stehlik, MD MPH

(801) 582-1565josef.stehlik@va.gov

Locations

VA Salt Lake City Health Care System, Salt Lake City, UT

Recruiting

Salt Lake City, Utah, United States, 84148-0001

Contacts

Heather Hanson, AAS BS

801-582-1565Heather.Hanson@va.gov

Principal Investigator:

Josef Stehlik, MD MPH

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • Heart Transplant
  • Empagliflozin
  • Safety and Tolerability
  • Kidney Outcomes
  • Cardiometabolic Outcomes
  • Erythropoiesis
  • Functional Status
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-22.