Actively Recruiting
DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Led by Oslo University Hospital · Updated on 2024-10-03
430
Participants Needed
6
Research Sites
312 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Heart transplant recipient at least 1 year after transplant
- Age 18 years or older
You will not qualify if you...
- Contraindications to the study medication
- Estimated glomerular filtration rate (GFR) less than 25 ml/min/m2
- Type 1 diabetes
- Severe liver failure (Child-Pugh score C)
- Life expectancy less than 2 years as judged by the investigator
- Unresolved malignant disease
- Unable or unwilling to provide written informed consent
- Treatment with SGLT2 inhibitors in the last month
- Pregnancy
- Breastfeeding
- Woman of child-bearing potential not willing to use highly effective birth control
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
2
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
3
Oslo University Hospital, Rikshospitalet
Oslo, Oslo, Norway, 0372
Actively Recruiting
4
Sahlgrenska University Hospital
Gothenburg, Sweden, SE-41345
Not Yet Recruiting
5
Skane University Hospital
Lund, Sweden, 22185
Not Yet Recruiting
6
Karolinska University Hospital
Stockholm, Sweden
Not Yet Recruiting
Research Team
K
Kaspar Broch, MD, PhD
CONTACT
L
Lars Gullestad, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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