DAPAgliflozin for Renal Protection in Heart Transplant Recipients

Condition(s) studied

Investigational drug(s) / intervention(s)

Dapagliflozin 10 mg: Participants will be randomized in a 1:1 fashion to receive 10 mg of oral dapagliflozin

Placebo: Participants will be randomized in a 1:1 fashion to receive a matching placebo once daily for one year.

Study summary

Kidney failure is common in heart transplant recipients and is a major cause of morbidity and mortality. Sodium-glucose transporter 2 (SGLT2) inhibitors were developed as antidiabetics but were subsequently shown to reduce the incidence of adverse cardiovascular outcomes and protect renal function in non-diabetics as well as diabetics. However, SGLT2 inhibitors have not been tested in clinical trials in heart transplant recipients. The DAPARHT trial is designed to assess the effect of the SGLT2 inhibitor dapagliflozin to prevent deteriorating renal function in heart transplant recipients. Secondary objectives are to assess the impact of treatment on i) weight, ii) glucose homeostasis, iii) proteinuria, iv) the number of rejections, and (v) safety and tolerability. As exploratory outcomes, the investigators will assess the effect of treatment on renal outcomes, clinical events (death, myocardial infarction, cerebral stroke, cancer, and end-stage renal disease), cardiac function, quality of life, and new-onset diabetes.

Eligibility

Primary outcome measure(s)

• The chronic slope of the eGFR — From 2 weeks to end-of-treatment (12 months)
  The primary endpoint will be the slope of the eGFR from 2 weeks to end-of-treatment (12 months), calculated as the difference in eGFR from two weeks to 12 months after start of the intervention.
• The change in eGFR from baseline — From 2 weeks to 1 month after end-of-treatment (37 months)
  Endpoints in open-label follow-up phase: The change in eGFR from baseline to 1 month after end-of-treatment, 37 months after start of the intervention

Trial sites (6)

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