| Trial ID: | L0966 |
| Source ID: | NCT06642272
|
| Associated Drug: |
Empagliflozin 10 Mg
|
| Title: |
A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
|
| Acronym: |
APPLE TREE
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Heart Failure|Chronic Kidney Diseases
|
| Interventions: |
DRUG: Empagliflozin 10 MG|DRUG: Dapagliflozin 10 MG
|
| Outcome Measures: |
Primary: 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., 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, Up to 24 months | Secondary: All-cause mortality, Up to 24 months|Hospitalization for heart failure, Up to 24 months|Hospitalization for myocardial infarction, Up to 24 months|Hospitalization for ischemic stroke, Up to 24 months|Incident or worsening nephropathy, 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, Up to 24 months|Hospitalization for coronary revascularization, Up to 24 months|Hospitalization for unstable angina, Up to 24 months | Other: Hospitalization for ketoacidosis, Safety outcome, Up to 24 months|Hospitalization for limb amputation, Safety outcome, Up to 24 months|Hospitalization for genitourinary infection, Safety outcome, Up to 24 months|Hospitalization for fracture, Safety outcome, Up to 24 months
|
| Sponsor/Collaborators: |
Sponsor: Herlev and Gentofte Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
17200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-10-10
|
| Completion Date: |
2028-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-05
|
| Locations: |
Bispebjerg Hospital, Copenhagen, Denmark|Rigshospitalet, Copenhagen, Denmark|Herlev and Gentofte Hospital, Herlev, Denmark|Steno Diabetes Center Copenhagen, Herlev, Denmark|Nordsjællands Hospital, Hillerød, Denmark|Holbæk Sygehus, Holbæk, Denmark|Hvidovre Hospital, Hvidovre, Denmark|Sjællands Universitetshospital, Køge, Denmark|Nykøbing F. Sygehus, Nykøbing Falster, Denmark|Sjællands Universitetshospital, Roskilde, Denmark|Bornholms Hospital, Rønne, Denmark|Slagelse Sygehus, Slagelse, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT06642272
|
