Randomized Trial of SGLT2i in Heart Transplant Recipients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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

Qualifiers

Age 18 years or older

Heart transplant recipient, 3 months after transplant

Disqualifiers

eGFR <20 mL/min/1.73m2

Type 1 diabetes mellitus

HbA1C >10%

Baseline UACR <30 mg/g in patients without T2D

Trial design

Treatments tested in this trial

  • Empagliflozin
  • Placebo

Treatment groups

200 Participants
are divided into 2 treatment groups