Trial record 2 of 8 for:    parkinson's disease PARS

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
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00202657     History of Changes
Other Study ID Numbers: 2005-03
Study First Received: September 12, 2005
Last Updated: December 5, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 23, 2014