Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide
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ClinicalTrials.gov Identifier: NCT00202657
Recruitment Status :
First Posted : September 20, 2005
Last Update Posted : December 6, 2011
Société Française de Cardiologie
Institut National de la Santé Et de la Recherche Médicale, France
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.
Condition or disease
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
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients treated with Pergolide for Parkinson disease or Patients with parkinson disease not treated with Pergolide
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)
Parkinson + syndrome, multiple system atrophy, supranuclear palsy