DAPAgliflozin for Renal Protection in Heart Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Aarhus University Hospital; Erasmus Medical Center; Karolinska University Hospital; Sahlgrenska University Hospital, Sweden; Skane University Hospital
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

1. Heart transplant recipient ≥ 1 year after heart transplant.

2. Age ≥ 18 years

Exclusion Criteria:

1. Contraindications to study medication.

2. Estimated GFR < 25 ml/min/m2

3. Type I diabetes

4. Severe liver failure (Child-Pugh's score C)

5. Life expectancy reduced to < 2 years as judged by the investigator

6. Unresolved malignant disease

7. Failure to obtain written informed consent

8. SGL2 inhibitor treatment over the last month

9. Pregnancy

10. Breast-feeding

11. Woman of child-bearing potential who is not willing to use a highly effective method of birth control