Study of the Effect of the Benfluorex
- Conditions
- Blood Sample
- Interventions
- Genetic: Sampling of blood
- Registration Number
- NCT02008552
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
More than 5 million persons in France exposed, in last years, to the taking of the Benfluorex.
Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were exposed during years without developing the slightest anomaly.
The hypothesis is the existence of a particular genetic susceptibility at the patients having developed a valvulopathy continuation in the exposure in this medicine.
Existence of one varying genetics with strong effect. The purpose is to identify involved genetic factors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 346
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mediagene Sampling of blood Sampling blood
- Primary Outcome Measures
Name Time Method Identify the genetic factors 12 months Identify the genetic factors involved in the individual susceptibility to develop a valvulopathy during a medicinal exposure in the benfluorex.
- Secondary Outcome Measures
Name Time Method Compare the quality of life 12 months Compare the quality of life of the cases and the witnesses via the completion of Two validated questionnaires of quality of life.
Trial Locations
- Locations (7)
Faculté de médecine Toulouse
🇫🇷Toulouse, France
Institut du Thorax Nantes
🇫🇷Nantes, France
Hôpital La Timone Marseille
🇫🇷Marseille, France
CHU de la Côte de Nacre Caen
🇫🇷Caen, France
Hôpital Sud Amiens
🇫🇷Amiens, France
CHRU de Brest
🇫🇷Brest, France
Hôpital Saint Philibert
🇫🇷Lomme, France