Using Dapagliflozin to Protect Kidneys in Heart Transplant Patients
DAPARHT: DAPAgliflozin for Renal Protection in Heart Transplant Recipients
This study is testing if the medication dapagliflozin can help protect the kidneys of heart transplant patients from failing.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 430 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 6 sites (Groningen and 5 other locations) |
| Trial ID | NCT05321706 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dapagliflozin, an SGLT2 inhibitor, on renal function in heart transplant recipients who are at risk of kidney failure. The study aims to determine whether dapagliflozin can prevent the deterioration of kidney function, while also assessing its impact on weight, glucose levels, proteinuria, and the incidence of transplant rejection. Participants will be monitored for safety and tolerability, as well as various clinical outcomes related to heart and kidney health. This is a Phase 3 interventional trial, indicating a focus on evaluating the efficacy and safety of the treatment in a larger patient population.
Who should consider this trial
Good fit: Ideal candidates are heart transplant recipients who are at least one year post-transplant and are 18 years or older.
Not a fit: Patients with severe kidney impairment, type I diabetes, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve kidney health and overall outcomes for heart transplant recipients.
How similar studies have performed: While SGLT2 inhibitors have shown promise in other populations, this specific application in heart transplant recipients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Groningen and 5 other locations
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
- Oslo University Hospital, Rikshospitalet — Oslo, Oslo, Norway (Recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)
- Skane University Hospital — Lund, Sweden (Not_yet_recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Olivier Manintveld, MD, PhD — Erasmus Medical Center
- Study coordinator: Kaspar Broch, MD, PhD
- Email: sbbrok@ous-hf.no
- Phone: +4792091824
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.