DAPAgliflozin for Renal Protection in Heart Transplant Recipients

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.

Conditions

• Heart Transplant Failure
• Kidney Failure

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.

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Olivier Manintveld, MD, PhD · Erasmus Medical Center

• Oscar Braun, MD, PhD · Skane University Hospital

• Ida H Löfman, MD, PhD · Karolinska University Hospital

• Kevin Damman, MD, PhD · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-08

Primary Completion

2026-04-30

Completion

2028-05-31

Countries

• Netherlands
• Norway
• Sweden

Study Locations