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

Completed

• Conditions: Parkinson's Disease; Pergolide

• Registration Number: NCT00202657
• Lead Sponsor: Société Française de Cardiologie

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

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2007-02
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Clinical Investigation Centre, Pitie-Salpetriere Hospital; 🇫🇷 Paris, France