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

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

This study is ongoing, but not recruiting participants.
Information provided by Société Française de Cardiologie

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin

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 Phase

Phase IV

Study Type ^†

Observational

Study Design ^†

Screening, Longitudinal, Convenience Sample, Prospective Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Parkinson's Disease
Pergolide

Intervention ^†

Procedure: echocardiography

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

149

Start Date ^†

April 2005

Completion Date

February 2007

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00202657

Organization ID

2005-03

Secondary IDs ^††

Study Sponsor ^†

Société Française de Cardiologie

Collaborators ^††

Institut National de la Santé Et de la Recherche Médicale, France

Investigators ^†

Principal Investigator:

Jean-Christophe CORVOL, MD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Société Française de Cardiologie

Verification Date

October 2006

First Received Date ^†

September 12, 2005

Last Updated Date

October 23, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.