DAPARHTDAPARHT: Dapagliflozin for Renal Protection in Heart Transplant Recipients
This study aims to evaluate the effectiveness of Dapagliflozin in protecting kidney function in heart transplant recipients, by observing changes in estimated Glomerular Filtration Rate (eGFR) from 2 weeks to the end of treatment (12 months).
Dapagliflozin 10 mg
+ Placebo
Urogenital Diseases+4
+ Female Urogenital Diseases and Pregnancy Complications
+ Kidney Diseases
Treatment Study
Summary
Study start date: June 8, 2022
Actual date on which the first participant was enrolled.The DAPARHT study focuses on heart transplant recipients, a group that often faces long-term side effects from immunosuppressive therapy. One such side effect is chronic renal failure, which occurs in about 11% of patients within five years post-transplant and significantly increases mortality. The study aims to evaluate the potential benefits of Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), in protecting against renal damage. SGLT2i drugs have shown promise in reducing hospitalization for heart failure and slowing kidney disease progression in patients with type 2 diabetes, and this study hopes to extend these benefits to heart transplant recipients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.430 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
University Medical Center Groningen
Groningen, NetherlandsOpen University Medical Center Groningen in Google MapsErasmus Medical Center
Rotterdam, NetherlandsOslo University Hospital, Rikshospitalet
Oslo, NorwayKarolinska University Hospital
Stockholm, Sweden