Last update : 01/01/2019 | Version : 1 | ID : 134
General | |
Identification | |
Detailed name | A 6 month follow-up o study of hospitalised patients with cardiac failure with Preserved systolic function (PSF-HF) in cardiology, internal medecine et geriatry |
Sign or acronym | I-SYPRES |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°908014 |
General Aspects | |
Medical area |
Cardiology |
Others (details) | cardiac insufficiency |
Keywords | Cardiac insufficiency, intact systolic function, Cardiology |
Scientific investigator(s) (Contact) | |
Name of the director | Herrmann |
Surname | Marie-Annick |
Address | 3, rue J. Monier - 92500 Rueil Malmaison |
Phone | +33 (0)1 58 83 60 00 |
marie-annick.herrmann@bms.com | |
Unit | Bristol-Myers Squibb |
Name of the director | Schmidely |
Surname | Nathalie |
Address | 3, rue J. Monier - 92500 Rueil Malmaison |
Phone | +33 (0)1 58 83 60 00 |
nathalie.schmidely@bms.com | |
Unit | Bristol-Myers Squibb |
Collaborations | |
Funding | |
Funding status |
Private |
Details | Bristol-Myers Squibb sanofi-aventis |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Bristol-Myers Squibb (BMS) |
Organisation status |
Private |
Sponsor(s) or organisation(s) responsible | Sanofi Aventis |
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 care professionals |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. | random sampling in clusters |
Database objective | |
Main objective | Determine the demographic characteristics and of the disease of patients hospitalized in the cardiology department for cardiac failure with intact systolic function |
Inclusion criteria |
Register Portion: M/F >=18 years, hospitalized for confirmed acute cardiac failure on the clinical symptoms and signs, Study Portion: Patient in the register, diagnosed for HF-ISF with an EF >45% evaluated within 8 days after the date of hospitalization |
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 | Metropolitan France |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2008 |
Date of last collection (YYYY or MM/YYYY) | 2009 |
Size of the database | |
Size of the database (number of individuals) |
< 500 individuals |
Details of the number of individuals | Registry: 700 Study: 364 |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Clinical data |
Clinical data (detail) |
Direct physical measures |
Presence of a biobank |
No |
Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
Procedures | |
Data collection method | Paper observation notebook |
Participant monitoring |
Yes |
Details on monitoring of participants | M0 and M6 |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) | Publication |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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