Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Heart Failure
Conditions
Brief summary
The aim of this clinical trial is investigate the comparative effectiveness of empagliflozin and dapagliflozin for the treatment of diabetes, chronic kidney disease, and heart failure. Patients who are prescribed either empagliflozin or dapagliflozin, as part of daily clinical practice at the participating sites, will be included in the study. Treatment will be randomized automatically through the electronic health record software in clusters defined by time of day. https://www.appletreestudy.com
Interventions
DRUGEmpagliflozin 10 MG
Once daily
DRUGDapagliflozin 10 MG
Once daily
Sponsors
Herlev and Gentofte Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Treatment assignment will be blinded to the statistician analysing the trial data.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or more
Exclusion criteria
* Incapabability of giving informed consent * Withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the first occurrence of any of the components of the composite: all-cause mortality, hospitalization for heart failure, hospitalization for myocardial infarction, hospitalization for ischemic stroke, and incident or worsening nephropathy. | Up to 24 months | Incident or worsening nephropathy is defined as: * A sustained decrease in estimated glomerular filtration rate (eGFR) of ≥40% from baseline * A sustained decrease in eGFR of ≤10 per minute per 1.73 m2 * Initiation of dialysis * Kidney transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization for myocardial infarction | Up to 24 months | — |
| Hospitalization for ischemic stroke | Up to 24 months | — |
| Incident or worsening nephropathy | Up to 24 months | Defined as a sustained decrease in estimated glomerular filtration rate (eGFR) of ≥40% from baseline, a sustained decrease in eGFR of ≤10 per minute per 1.73 m2, initiation of dialysis, or kidney transplantation |
| Hospitalization for coronary revascularization | Up to 24 months | — |
| Hospitalization for unstable angina | Up to 24 months | — |
| All-cause mortality | Up to 24 months | — |
| Hospitalization for heart failure | Up to 24 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization for genitourinary infection | Up to 24 months | Safety outcome |
| Hospitalization for fracture | Up to 24 months | Safety outcome |
| Hospitalization for ketoacidosis | Up to 24 months | Safety outcome |
| Hospitalization for limb amputation | Up to 24 months | Safety outcome |
Countries
Denmark
Contacts
Primary ContactMorten Schou, Professor
Backup ContactDaniel M. Christensen, MD, PhD
Outcome results
None listed