DAPAgliflozin for Renal Protection in Heart Transplant Recipients

Sponsor
Oslo University Hospital
Study ID
NCT05321706
Phase
PHASE3
Status
Recruiting
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Conditions

  • Heart Transplant Failure
  • Kidney Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 mg — DRUG
    Participants will be randomized in a 1:1 fashion to receive 10 mg of oral dapagliflozin
  • Placebo — DRUG
    Participants will be randomized in a 1:1 fashion to receive a matching placebo once daily for one year.

Study Details

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.

Key Dates

Start date
Jun 8, 2022
Status verified
Oct 2024
Primary completion
Apr 30, 2026
Completion
May 31, 2028

Study Design

Enrollment
430 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    Participants will be randomized in a 1:1 fashion to receive 10 mg of oral dapagliflozin (tablet) once daily for one year.
  • Placebo Comparator: Placebo
    Participants will be randomized in a 1:1 fashion to receive a matching tablet once daily for one year.

Primary Outcome Measure

The chronic slope of the eGFR [ Time Frame: From 2 weeks to end-of-treatment (12 months) ]

Central Contacts

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