REFLEX - Longitudinal Study on Aortic Regurgitation in Patients Treated with Benfluorex

Head :
Zureik Mahmoud, 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

Last update : 07/08/2015 | Version : 1 | ID : 8761

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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 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
Email 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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