DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Launched by OSLO UNIVERSITY HOSPITAL · Apr 4, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The DAPAgliflozin for Renal Protection in Heart Transplant Recipients trial, also known as the DAPARHT trial, is studying how a medication called dapagliflozin can help protect kidney function in people who have received a heart transplant. Kidney problems are common in heart transplant patients and can lead to serious health issues. This trial will evaluate not only how well dapagliflozin works for kidney protection but also its effects on weight, blood sugar levels, protein in the urine, and the overall safety of the medication. Researchers are also interested in understanding how this treatment might affect heart health, quality of life, and the risk of other serious conditions.
To participate in the trial, individuals must be at least 18 years old and must have had their heart transplant for at least one year. However, there are certain health conditions that would exclude someone from participating, such as severe kidney problems, type I diabetes, or being pregnant. The study is currently looking for volunteers, and participants can expect to receive the study medication while being closely monitored for any changes in their health. This trial represents an important step in finding better ways to support kidney health in heart transplant recipients.
Gender
ALL
Eligibility 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
About Oslo University Hospital
Oslo University Hospital is a leading academic medical center in Norway, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes the development of new therapies and treatment strategies. With a multidisciplinary approach, Oslo University Hospital collaborates with various stakeholders, including researchers, healthcare professionals, and industry partners, to enhance clinical outcomes and contribute to the global medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and respect for participant welfare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rotterdam, , Netherlands
Stockholm, , Sweden
Groningen, , Netherlands
Lund, , Sweden
Gothenburg, , Sweden
Oslo, , Norway
Skejby, , Denmark
Patients applied
Trial Officials
Olivier Manintveld, MD, PhD
Principal Investigator
Erasmus Medical Center
Oscar Braun, MD, PhD
Principal Investigator
Skane University Hospital
Ida H Löfman, MD, PhD
Principal Investigator
Karolinska University Hospital
Kevin Damman, MD, PhD
Principal Investigator
University Medical Center Groningen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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