SISTOLA - Observational usage and effectiveness of candesartan in heart failure treatment in France ARCHIVE

Head :
Thomas-Delcourt Florence, AstraZeneca

Last update : 01/01/2020 | Version : 2 | ID : 195

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Observational usage and effectiveness of candesartan in heart failure treatment in France
Sign or acronym SISTOLA
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL approval : 907230 - 27 November 2007
General Aspects
Medical area Cardiology
Others (details) Congestive heart failure
Keywords candesartan
Scientific investigator(s) (Contact)
Name of the director Thomas-Delcourt
Surname Florence
Phone +33 (1) 41 29 40 25
Email florence.thomas@astrazeneca.com
Unit AstraZeneca
Collaborations
Funding
Funding status Private
Details AstraZeneca / Takeda
Governance of the database
Sponsor(s) or organisation(s) responsible ASTRAZENECA / TAKEDA
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Database objective
Main objective To describe the way candesartan is used in heart failure treatment in France (treatment initiation and follow-up) treatment discontinuation occurences and reasons why and patients clinical evolution
Inclusion criteria Patients starting or who have recently started (less than 30 days) a treatment with candesartan for heart failure
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area Consultation in cardiology
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2008
Date of last collection (YYYY or MM/YYYY) 2010
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 452
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Phone interview
Biological data (detail) ionogram, with blood potassium in particular, natremia and kidney function
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Participant monitoring Yes
Details on monitoring of participants 12 months
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Methods for accessing the database are currently being defined
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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