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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00202657
First Posted: September 20, 2005
Last Update Posted: December 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Société Française de Cardiologie
  Purpose
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.

Condition Intervention Phase
Parkinson's Disease Pergolide Procedure: echocardiography Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin

Resource links provided by NLM:


Further study details as provided by Société Française de Cardiologie:

Enrollment: 149
Study Start Date: April 2005
Estimated Study Completion Date: February 2007
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with Pergolide for Parkinson disease or Patients with parkinson disease not treated with Pergolide
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202657


Locations
France
Clinical Investigation Centre, Pitie-Salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
Société Française de Cardiologie
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Jean-Christophe CORVOL, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00202657     History of Changes
Other Study ID Numbers: 2005-03
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by Société Française de Cardiologie:
parkinson's disease
pergolide
heart valve disease

Additional relevant MeSH terms:
Parkinson Disease
Heart Valve Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Heart Diseases
Cardiovascular Diseases
Pergolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs