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

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Société Française de Cardiologie
ClinicalTrials.gov Identifier:
NCT00202657
First received: September 12, 2005
Last updated: December 5, 2011
Last verified: December 2011

September 12, 2005
December 5, 2011
April 2005
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Complete list of historical versions of study NCT00202657 on ClinicalTrials.gov Archive Site
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Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide
Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin

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.

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients treated with Pergolide for Parkinson disease or Patients with parkinson disease not treated with Pergolide

  • Parkinson's Disease
  • Pergolide
Procedure: echocardiography
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
February 2007
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00202657
2005-03
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Société Française de Cardiologie
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Jean-Christophe CORVOL, MD Assistance Publique - Hôpitaux de Paris
Société Française de Cardiologie
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP