Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
346 participants
INTERVENTIONAL
2013-10-18
2021-10-18
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Mediagene
Sampling blood
Sampling of blood
Sampling of blood was taken and analyse to research factor genetic
Interventions
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Sampling of blood
Sampling of blood was taken and analyse to research factor genetic
Eligibility Criteria
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Inclusion Criteria
* 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 .
* 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
* 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.
\- Individual having explicitly refused to participate in the study.
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Irène Frachon, PH
Role: PRINCIPAL_INVESTIGATOR
CHRU de Brest
Locations
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Hôpital Sud Amiens
Amiens, , France
CHRU de Brest
Brest, , France
CHU de la Côte de Nacre Caen
Caen, , France
Hôpital Saint Philibert
Lomme, , France
Hôpital La Timone Marseille
Marseille, , France
Institut du Thorax Nantes
Nantes, , France
Faculté de médecine Toulouse
Toulouse, , France
Countries
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Other Identifiers
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MEDIAGENE
Identifier Type: -
Identifier Source: org_study_id