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DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Sponsor: Oslo University Hospital
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.
Official title: DAPARHT: DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
430
Start Date
2022-06-08
Completion Date
2028-05-31
Last Updated
2024-10-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (6)
University Medical Center Groningen
Groningen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Oslo University Hospital, Rikshospitalet
Oslo, Oslo County, Norway
Sahlgrenska University Hospital
Gothenburg, Sweden
Skane University Hospital
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden