ITMO public health
Last update : 01/01/2020 | Version : 2 | ID : 195
| 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 |
| 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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