ITMO public health
Last update : 07/08/2015 | Version : 1 | ID : 8761
| General | |
| Identification | |
| Detailed name | Longitudinal Study on Aortic Regurgitation in Patients Treated with Benfluorex |
| Sign or acronym | REFLEX |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL no. 1286925 |
| General Aspects | |
| Medical area |
Cardiology |
| Health determinants |
Medicine |
| Keywords | Benfluorex, marketing authorisation, MA, research, side effects, post, adverse events, study |
| Scientific investigator(s) (Contact) | |
| Name of the director | Zureik |
| Surname | Mahmoud |
| Address | Faculté de médecine site Xavier Bichat 16 rue Henri Huchard BP 416 75870 Paris CEDEX 18 |
| Phone | +33 (0)1 57 27 75 65 |
| mahmoud.zureik@inserm.fr | |
| Unit | U1152 Physiopathologie et épidémiologie des maladies respiratoiresÉquipe/activité :- Épidémiologie respiratoire: de l'étiologie de l'asthme et de la BPCO au pronostic de la transplantation pulmonaire |
| Organization | Institut national de la santé et de la recherche médicale - |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Ministry of Health. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut national de la santé et de la recherche médicale - Inserm |
| Organisation status |
Public |
| 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 |
| Additional information regarding sample selection. | Patients that meet the inclusion criteria are consecutively and systematically enrolled for one year. |
| Database objective | |
| Main objective |
Echocardiography-based study on the development of valvular disease (decrease, stable, increase) in patients treated with benfluorex.
To compare the development of valvular diseases potentially linked to benfluorex and diseases not linked to benfluorex. - All patients and patients with valvular disease potentially linked to benfluorex; assessment of development with regards to: - Indication(s), duration of exposure to benfluorex and duration since stopping medication. - Age and sex; - diabetes and associated medical treatment. - Presence of cardiac and non-cardiac diseases; - current treatments and treatments that were undergone simultaneously with benfluorex. |
| Inclusion criteria |
- Male and female;
- Adult; - Patient treated with benfluorex from 2006-2009 with aortic/mitral grade regurgitation. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 60 cardiology centres throughout France. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 1,000 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | --- |
| Paraclinical data (detail) | Echocardiography. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Clinical and echocardiography data will be recorded at enrolment and follow-up visits. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Additional visits will be provided if necessary, as part of regular patient monitoring. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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