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RECRUITING
NCT05321706
PHASE3

DAPAgliflozin for Renal Protection in Heart Transplant Recipients

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Dapagliflozin 10 mg

Participants will be randomized in a 1:1 fashion to receive 10 mg of oral dapagliflozin

DRUG

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