Cardiac Failure Renal dysfunction
Conditions
Interventions
After the participant has provided informed consent, he or she will be
randomised to receive oral dapagliflozin or a matching placebo. The
randomisation process will be performed online via the comm
whereas patients allocated to placebo will enter the
open-label phase without treatment beyond the standard of care. Both groups
will be followed-up for safety and efficacy as specified in the study
whereas
patients assigned to placebo will continue standard-of-care treatment.
The patients will self-administer the investigational drug.
Sponsors
Oslo University Hospital
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Heart transplant recipient >= 1 year after heart transplant. 2. Age >= 18 years
Exclusion criteria
Exclusion criteria: 1. Contraindications to study medication. 2. Estimated GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The chronic slope of the eGFR from 2 weeks to end-of-treatment (12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1. Change in body weight 2. The change in the albumin/creatinine ratio in the urine from baseline to end-of-treatment in patients with a baseline ratio > 30 mg/g at baseline 3. The change in the blood level of glycated haemoglobin (HbA1c) in patients with diabetes mellitus | — |
Countries
Netherlands
Outcome results
None listed