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NCT00202657 Clinical Trial

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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00202657
Other study ID # 2005-03
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated December 5, 2011
Start date April 2005
Est. completion date February 2007

Study information
Verified date December 2011
Source Société Française de Cardiologie
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 149
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• echocardiography

Locations
Country Name City State
France Clinical Investigation Centre, Pitie-Salpetriere Hospital Paris

Sponsors (2)
Lead Sponsor Collaborator
Société Française de Cardiologie Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

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