Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine whether patients with Parkinson's disease and treated with pergolide have a higher risk of heart valve disease compared to patients with Parkinson's disease not treated with pergolide.
详细描述
Pergolide is an ergot dopamine receptor agonist with demonstrated efficacy in Parkinson's disease. Last year, two studies showed that pergolide can induce unexpected heart valve disease potentially severe and frequent. The late discovery of this unknown side effect had dramatic consequences in Parkinson's disease management and the French drug agency (AFFSAPS) has recently published guidelines for its prescription. Little is known about the prevalence and the molecular mechanisms leading to this adverse event. To determine the prevalence, evolution, and potential risk factors of pergolide-induced heart valve disease, we propose an echocardiographic observational study in parkinsonian patients taking pergolide compared to matched controls. This clinical study will be performed in the Clinical Investigation Centre in collaboration with the Institute of Cardiology of the Salpétrière Hospital
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Idiopathic Parkinson's disease
- •Hoehn and Yahr score inferior or equal to 4
- •treated with pergolide since more than 3 months (pergolide group)
- •never treated by pergolide (control group)
排除标准
- •Parkinson + syndrome, multiple system atrophy, supranuclear palsy
- •hoehn and yahr score equal to 5
