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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.
First Received: September 12, 2005   Last Updated: October 23, 2006   History of Changes
Sponsor: Société Française de Cardiologie
Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
Information provided by: Société Française de Cardiologie
ClinicalTrials.gov Identifier: NCT00202657
  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 IV

Study Type: Observational
Study Design: Screening, Longitudinal, Convenience Sample, Prospective Study
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:

Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Société Française de Cardiologie

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 2005-03
Study First Received: September 12, 2005
Last Updated: October 23, 2006
ClinicalTrials.gov Identifier: NCT00202657     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

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

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

ClinicalTrials.gov processed this record on November 05, 2009