Study of the Effect of the Benfluorex

Study Overview
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Brief Summary
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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.

Official Title
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Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in the Benfluorex.

Conditions
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Blood Sample

Intervention / Treatment
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* Genetic: Sampling of blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria of the cases : Individual presenting a typical medicinal valvulopathy defined by: A previous exposure of at least 6 months in the benfluorex or occasional exposure accepted about is the posology. The preliminary exposure in the dexfenfluramine or in the fenfluramine is authorized. A picture board of insufficiency mitral restrictive and/or aortic restrictive (in echocardiography) typical of a medicinal achievement, a gravity (rank I - IV), without cause associated of valvulopathy with compatible macroscopic and histological aspect (for the operated patients). Individual followed in one of the sites of study or recruited via associations AVIM and CADUS. Individual of Caucasian origin Individual having signed the form of specific consent for the study individual . Inclusion criteria of witnesses : Individual presenting an exposure previous to the benfluorex superior or equal to the equivalent of 2 years of treatment in 3 tablets a day and pursued to 2 years preceding the realization of a cardiac echography of screening. The preliminary exposure in the dexfenfluramine or in the fenfluramine is authorized. Individual presenting a strictly normal cardiac echography in particular: absence of valvulopathy significant, of morphological valvular anomaly (event without echography) and of valvular, including trivial leak at the aortic level. The mitrals micro leaks physiological are accepted. Individual having been seen for screening in one of the sites of study or in in French firms cardilogie which cardiologists are members of the French Society of Cardiologyor or via the law firms of the civil parties or having been included in the forward-looking study coordinated by Pr. TRIBOUILLOY (which the objective is to compare the echography data of a group of patients having been treated at least 3 months in the benfluorex and with a group of patients diabetics having never received this medicine). Individual of Caucasian origin. Individual having signed the form of specific consent for the study Exclusion criteria of the cases: Individual presenting another associated heart disorder. Individual having been exposed to another agonists of the receivers 5-HT2B such as the pergolide, the cabergoline, the lisuride, the quibbled by-products or the ecstasy. Individual having explicitly refused to participate in the study. Exclusion criteria of witnesses : - Individual having explicitly refused to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mediagene<br>Sampling blood | Genetic: Sampling of blood<br>* Sampling of blood was taken and analyse to research factor genetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the genetic factors | Identify the genetic factors involved in the individual susceptibility to develop a valvulopathy during a medicinal exposure in the benfluorex. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the quality of life | Compare the quality of life of the cases and the witnesses via the completion of Two validated questionnaires of quality of life. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic factor, Valvulopathy, Mediator