NCT02008552已完成不适用
Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in the Benfluorex.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 7
- 主要终点
- Identify the genetic factors
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Mediagene
Other
Sampling blood
干预措施: Sampling of blood (Genetic)
结局指标
主要结局
Identify the genetic factors
时间窗: 12 months
Identify the genetic factors involved in the individual susceptibility to develop a valvulopathy during a medicinal exposure in the benfluorex.
次要结局
- Compare the quality of life(12 months)
研究者
研究点 (7)
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