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

Inclusion Criteria2

  • Heart transplant recipient ≥ 1 year after heart transplant.
  • Age ≥ 18 years

Exclusion Criteria11

  • Contraindications to study medication.
  • Estimated GFR \< 25 ml/min/m2
  • Type I diabetes
  • Severe liver failure (Child-Pugh's score C)
  • Life expectancy reduced to \< 2 years as judged by the investigator
  • Unresolved malignant disease
  • Failure to obtain written informed consent
  • SGL2 inhibitor treatment over the last month
  • Pregnancy
  • Breast-feeding
  • Woman of child-bearing potential who is not willing to use a highly effective method of birth control

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 County, Norway

Sahlgrenska University Hospital

Gothenburg, Sweden

Skane University Hospital

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden

View Full Details on ClinicalTrials.gov

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NCT05321706


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