Clinical trial NCT02008552: Study of the Effect of the Benfluorex
Official title: Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in the Benfluorex.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Sample
Keywords: Genetic factor
Valvulopathy
Mediator
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2013-12-11
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Identify the genetic factors
timeFrame: 12 months
Secondary outcomes:
measure: Compare the quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hôpital Sud Amiens
city: Brest
country: France
facility: CHRU de Brest
city: Caen
country: France
facility: CHU de la Côte de Nacre Caen
city: Lomme
country: France
facility: Hôpital Saint Philibert
city: Marseille
country: France
facility: Hôpital La Timone Marseille
city: Nantes
country: France
facility: Institut du Thorax Nantes
city: Toulouse
country: France
facility: Faculté de médecine Toulouse
Study officials:
affiliation: CHRU de Brest
name: Irène Frachon, PH
role: PRINCIPAL_INVESTIGATOR
References: