Status: Planned First registered on: 09/10/2020
Last updated on: 16/10/2020
1. Study identification
EU PAS Register NumberEUPAS37569
Official titleCardiovascular-Renal-Metabolism comorbidity epidemiology and healthcare utilisation – Observational studies across Europe – French part of the study program
Study title acronymCaReMe Europe
Study typeOther: Historical cohort study using the SNDS, the French nationwide claims database
Brief description of the studyCommonalities between cardiovascular, renal and metabolic (CaReMe) diseases with clinical overlap between these diseases and their associated complications are increasingly recognized. AstraZeneca conducts a European study program in 10 countries according to a common protocol to address specific unanswered questions on the epidemiology of CaReMe disorders and the impact of these on healthcare utilization, using the French claims database (SNDS) for the French part of the program. The French cohort will include all adult type 2 diabetes (T2D) patients in 2014 with a follow-up of 5 years and having 4-year history period before the index date (01/01/2014) in the database. The cardiovascular and renal disease-free T2D population will include all T2D patients without angina, unstable angina, atrial fibrillation, myocardial infarction (MI), heart failure (HF), coronary revascularisation, stroke, transient ischemic attack, peripheral artery disease (PAD), peripheral artery revascularisation, chronic kidney disease (CKD) or dispensing of nitrates within the 4-year period before the index date. Several co-morbid T2D populations will be defined as cardiorenal syndrome (HF and CKD) population, HF population, CKD population, stroke population, MI population and PAD population. It is expected for the study approximately 3 million of T2D population in 2015. The events of interest (cardiorenal disease [HF or CKD], HF, CKD, PAD, MI, stroke, and all-cause death) during the study period will be described in terms of crude incidence rate (person-year), cumulative incidence/probability (in %, Kaplan-Meier estimator or Cumulative Incidence Function), and risk comparison for each event between disease-free and co-morbid populations (Cox proportional hazards model or Fine and Grey Model). Specific cost (all payer perspective) of HF, CKD, cardiorenal diseases (HF or CKD), PAD, MI, or stroke will be estimated during the follow-up in T2D patients free from cardiovascular and renal diseases.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Blin
First name Patrick
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed26/09/2019
Start date of data collection31/10/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report31/03/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1146 Rue Leo Saignat
Address line 2University of Bordeaux - Bordeaux PharmacoEpi, INSERM CIC1401 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1146 Rue Leo Saignat 
Address line 2University of Bordeaux - Bordeaux PharmacoEpi, INSERM CIC1401 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
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