DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Status:
Not yet recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Oslo University Hospital
Collaborators:
Aarhus University Hospital Erasmus Medical Center Karolinska University Hospital Sahlgrenska University Hospital, Sweden Skane University Hospital