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Sponsors and Collaborators: |
Société Française de Cardiologie Institut National de la Santé Et de la Recherche Médicale, France |
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Information provided by: | Société Française de Cardiologie |
ClinicalTrials.gov Identifier: | NCT00202657 |
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 |
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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 |
Estimated Enrollment: | 149 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | February 2007 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Clinical Investigation Centre, Pitie-Salpetriere Hospital | |
Paris, France, 75013 |
Principal Investigator: | Jean-Christophe CORVOL, MD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | 2005-03 |
Study First Received: | September 12, 2005 |
Last Updated: | October 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00202657 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
parkinson's disease pergolide heart valve disease |
Dopamine Ganglion Cysts Heart Diseases Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Pergolide Heart Valve Diseases |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases |
Dopamine Agents Cardiovascular Diseases Dopamine Agonists Pharmacologic Actions |