DAPAgliflozin for renal protection in heart transplant recipients. Rationale and design of the randomized controlled DAPARHT trial.
Stine Holmen, Olivier Manintveld, Kevin Damman...
https://pubmed.ncbi.nlm.nih.gov/40840822Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05321706
DAPARHT: Dapagliflozin for Kidney Protection in Heart Transplant Recipients
Led by Oslo University Hospital · Updated on 2024-10-03
430
Participants Needed
6
Research Sites
108 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 a common and serious problem for people who have received a heart transplant, often leading to increased illness and death. Researchers are studying dapagliflozin, a type of sodium-glucose transporter 2 (SGLT2) inhibitor originally developed for diabetes, to see if it can protect kidney function in heart transplant recipients. This trial aims to evaluate whether dapagliflozin can slow kidney function decline and also looks at effects on weight, blood sugar control, protein in urine, rejection episodes, safety, and quality of life. Participants will be randomly assigned to receive either 10 mg of oral dapagliflozin or a matching placebo tablet once daily for one year. The study is double-blind, meaning neither the participants nor the researchers know which treatment is given. The trial is designed to carefully monitor kidney function over the treatment period and compare the effects of dapagliflozin to placebo. Secondary assessments include measurements of body weight, blood sugar levels (HbA1c), and proteinuria. Throughout the study, participants will have regular evaluations including kidney function tests to measure the estimated glomerular filtration rate (eGFR), blood tests, and urine tests. Researchers will track changes from two weeks after starting treatment through the end of the 12-month study. Safety and tolerability will also be monitored closely. These assessments help determine the impact of dapagliflozin on kidney health and overall wellbeing in heart transplant patients.
CONDITIONS
Brief Title
DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Who Can Participate
Age: 18Years +
All Genders
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 study medication
- Estimated GFR less than 25 ml/min/m2
- Type 1 diabetes
- Severe liver failure (Child-Pugh's score C)
- Life expectancy less than 2 years as judged by investigator
- Unresolved malignant disease
- Failure to obtain written informed consent
- Use of SGLT2 inhibitor treatment in the last month
- Pregnancy
- Breastfeeding
- Woman of child-bearing potential not willing to use highly effective birth control
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 year
Participants take either 10 mg of oral dapagliflozin or a matching placebo once daily for one year to assess kidney protection after heart transplant.
Regular visits during the treatment period to monitor kidney function and other health measures
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
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Research Team
K
Kaspar Broch, MD, PhD
L
Lars Gullestad, MD, PhD
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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Published Research Related To This Trial
Management of Kidney Disease in Heart Transplant Patients: A National Delphi Survey-based Consensus Expert Paper.
María Dolores García-Cosío Carmena, Marta Farrero, María Teresa Blasco Peiró...
https://pubmed.ncbi.nlm.nih.gov/39928546