DAPAgliflozin for Renal Protection in Heart Transplant Recipients

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.

NCT Number	NCT05321706
Lead Sponsor	Oslo University Hospital Collaborators: Erasmus Medical Center, Skane University Hospital, Aarhus University Hospital, Karolinska University Hospital, Sahlgrenska University Hospital
Conditions	Heart Transplant Failure, Kidney Failure
Enrollment	430 participants
Start Date	2022-06-08
Primary Completion	2028-09-30 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-01