DAPARHT: DAPAgliflozin for Renal Protection in Heart Transplant Recipients

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Heart transplant recipient ≥ 1 year after heart transplant.

• Age ≥ 18 years

Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Erasmus Medical Center
RECRUITING
Rotterdam
Norway
Oslo University Hospital, Rikshospitalet
RECRUITING
Oslo
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Skane University Hospital
NOT_YET_RECRUITING
Lund
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Contact Information
Primary
Kaspar Broch, MD, PhD
sbbrok@ous-hf.no
+4792091824
Backup
Lars Gullestad, MD, PhD
lars.gullestad@medisin.uio.no
+4797644772
Time Frame
Start Date: 2022-06-08
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 430
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska University Hospital, Sahlgrenska University Hospital, Erasmus Medical Center, Skane University Hospital, Aarhus University Hospital
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov