RecruitingPhase 3NCT05321706

DAPAgliflozin for Renal Protection in Heart Transplant Recipients

DAPARHT: DAPAgliflozin for Renal Protection in Heart Transplant Recipients


Sponsor

Oslo University Hospital

Enrollment

430 participants

Start Date

Jun 8, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether dapagliflozin (an SGLT2 inhibitor, a type of diabetes/heart drug) can protect kidney function in heart transplant recipients who develop kidney problems after transplant. **You may be eligible if...** - You have received a heart transplant - You are experiencing declining kidney function after transplant - You are 18 or older - You are on stable immunosuppression **You may NOT be eligible if...** - You have Type 1 diabetes - You have a history of recurrent urinary tract infections - You are on dialysis - You are pregnant or planning pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDapagliflozin 10 mg

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

DRUGPlacebo

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, Norway

Sahlgrenska University Hospital

Gothenburg, Sweden

Skane University Hospital

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05321706


Related Trials