NCT05321706Active, not recruitingPhase 3
DAPAgliflozin for Renal Protection in Heart Transplant Recipients
DAPARHT: DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 430 (estimated)
- First submitted
- 22 Mar 2022
- Start date
- 8 Jun 2022
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Oslo University Hospital
- NCT number
- NCT05321706
- EU CT number
- 2023-506486-60-01
- EudraCT number
- 2021-003175-34
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 430
- From 8 Jun 2022 to the primary completion date, 30 Sept 2028
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to study medication.
- SGL2 inhibitor treatment over the last month
Other illness
- Type I diabetes
- Severe liver failure (Child-Pugh's score C)
- Unresolved malignant disease
- Failure to obtain written informed consent
Lab values
- Estimated GFR \< 25 ml/min/m2
Age
- Life expectancy reduced to \< 2 years as judged by the investigator
Other
- Pregnancy
- Breast-feeding
- Woman of child-bearing potential who is not willing to use a highly effective method of birth control
Who the study is looking for
- Heart transplant recipient ≥ 1 year after heart transplant.
- Age ≥ 18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Active, not recruiting |
| Lund University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.