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Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide

S

Société Française de Cardiologie

Status

Completed

Conditions

Parkinson's Disease
Pergolide

Treatments

Procedure: echocardiography

Study type

Observational

Funder types

Other

Identifiers

NCT00202657
2005-03

Details and patient eligibility

About

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.

Full 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

Enrollment

149 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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