Status:
RECRUITING
DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Erasmus Medical Center
Skane University Hospital
Conditions:
Heart Transplant Failure
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 subseq...
Detailed Description
Heart transplant is the treatment of choice for selected patients with end-stage heart failure. Worldwide, approximately 5000 procedures are performed annually. Whereas the first successful heart tran...
Eligibility Criteria
Inclusion
- Heart transplant recipient ≥ 1 year after heart transplant.
- Age ≥ 18 years
Exclusion
- 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
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT05321706
Start Date
June 8 2022
End Date
May 31 2028
Last Update
October 3 2024
Active Locations (6)
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1
University Medical Center Groningen
Groningen, Netherlands
2
Erasmus Medical Center
Rotterdam, Netherlands
3
Oslo University Hospital, Rikshospitalet
Oslo, Oslo County, Norway, 0372
4
Sahlgrenska University Hospital
Gothenburg, Sweden, SE-41345