Clinical trial NCT06642272: A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
Official title: A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Heart Failure
Chronic Kidney Diseases
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 17200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or more

Exclusion Criteria:

* Incapabability of giving informed consent
* Withdrawal of informed consent

Primary outcomes:
measure: 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.
timeFrame: Up to 24 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: Up to 24 months
measure: Hospitalization for heart failure
timeFrame: Up to 24 months
measure: Hospitalization for myocardial infarction
timeFrame: Up to 24 months
measure: Hospitalization for ischemic stroke
timeFrame: Up to 24 months
measure: Incident or worsening nephropathy
timeFrame: Up to 24 months
measure: Hospitalization for coronary revascularization
timeFrame: Up to 24 months
measure: Hospitalization for unstable angina
timeFrame: Up to 24 months
Other outcomes:
measure: Hospitalization for ketoacidosis
timeFrame: Up to 24 months
measure: Hospitalization for limb amputation
timeFrame: Up to 24 months
measure: Hospitalization for genitourinary infection
timeFrame: Up to 24 months
measure: Hospitalization for fracture
timeFrame: Up to 24 months
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Køge
country: Denmark
facility: Sjællands Universitetshospital
city: Nykøbing Falster
country: Denmark
facility: Nykøbing F. Sygehus
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital
city: Rønne
country: Denmark
facility: Bornholms Hospital
city: Slagelse
country: Denmark
facility: Slagelse Sygehus
Study officials:
References: