Parkinson's Disease, Pergolide
Conditions
Keywords
parkinson's disease, pergolide, heart valve disease
Brief summary
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.
Detailed description
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
Interventions
PROCEDUREechocardiography
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Société Française de Cardiologie
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Parkinson + syndrome, multiple system atrophy, supranuclear palsy * hoehn and yahr score equal to 5
Countries
France
Outcome results
None listed