Health TrialsbyHealthPanel

Randomized Trial of SGLT2i in Heart Transplant Recipients

ConditionsHeart TransplantCardiovascular DiseaseKidney Disease
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin

    Drug

    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

    Drug

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: EmpagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Urinary albumin-to-creatinine ratio (UACR)

UACR difference (mg/g) in subjects in active arm vs control arm

Time frame
12 months
2

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Adverse and serious adverse events difference in active arm vs control arm

Time frame
12 months

Secondary outcomes

1

Estimated Glomerular Filtration Rate (eGFR)

eGFR difference (mL/min/1.73m2) in subjects in active arm vs control arm

Time frame
12 months
2

Hemoglobin A1c (HbA1c)

HbA1c difference (%) in subjects in active arm vs control arm

Time frame
12 months
3

Fasting blood glucose

Fasting blood glucose difference (mg/dL) in subjects in active arm vs control arm

Time frame
12 months
4

Body weight

Body weight difference (kg) in subjects in active arm vs control arm

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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