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

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. Identifier: NCT00202657
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 6, 2011
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Société Française de Cardiologie

Brief 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.

Condition or disease Intervention/treatment
Parkinson's Disease Pergolide Procedure: echocardiography

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

Study Type : Observational
Actual Enrollment : 149 participants
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
Study Start Date : April 2005
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 identifier (NCT number): NCT00202657

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
Principal Investigator: Jean-Christophe CORVOL, MD Assistance Publique - Hôpitaux de Paris

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

Keywords provided by Société Française de Cardiologie:
parkinson's disease
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
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs