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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-02-28

Brief Summary

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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

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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

Conditions

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Parkinson's Disease Pergolide

Keywords

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parkinson's disease pergolide heart valve disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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echocardiography

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jean-Christophe CORVOL, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Clinical Investigation Centre, Pitie-Salpetriere Hospital

Paris, , France

Site Status

Countries

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France

References

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Corvol JC, Anzouan-Kacou JB, Fauveau E, Bonnet AM, Lebrun-Vignes B, Girault C, Agid Y, Lechat P, Isnard R, Lacomblez L. Heart valve regurgitation, pergolide use, and parkinson disease: an observational study and meta-analysis. Arch Neurol. 2007 Dec;64(12):1721-6. doi: 10.1001/archneur.64.12.1721.

Reference Type DERIVED

PMID: 18071034 (View on PubMed)

Other Identifiers

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2005-03

Identifier Type: -

Identifier Source: org_study_id