ITMO public health
Last update : 01/01/2019 | Version : 1 | ID : 89
| General | |
| Identification | |
| Detailed name | Observational study on the diagnostic elements of Heart Failure with Preserved Systolic Function (HF-PSF) in private practice |
| Sign or acronym | I-SYPRES |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n° 907194 |
| General Aspects | |
| Medical area |
Cardiology |
| Others (details) | Heart Failure with Preserved Systolic Function |
| Keywords | metabolic and cardiological risk factors |
| Scientific investigator(s) (Contact) | |
| Name of the director | Vignal |
| Surname | Franck |
| Phone | +33 (0)1 57 63 26 47 |
| franck.vignal@sanofi-aventis.com | |
| Unit | Sanofi Aventis |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | sanofi-aventis |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-aventis France |
| 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. | Consecutive inclusion of 4 eligible patients per physician |
| Database objective | |
| Main objective |
Describe in private cardiology practice the diagnostic elements of Heart Failure with Preserved Systolic Function (HF-PSF) for patients: - for whom the private cardiologist makes an initial diagnosis of HF-PSF, - monitored through appointments and for whom the HF-PSF diagnosis was made during hospitalization |
| Inclusion criteria | Aged over 18; Presenting HF-PSF that has been diagnosed in the past 6 months either by a private cardiologist or during hospitalization; Agreeing to take part in the study |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2007 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1168 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Biological data (detail) | creatinine levels, blood sodium levels, blood glucose, hemoglobin levels |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 6 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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