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| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | October 23, 2006 | ||||
| Start Date ICMJE | April 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00202657 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide | ||||
| Official Title ICMJE | Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin | ||||
| 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. |
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| 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 |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Screening, Longitudinal, Convenience Sample, Prospective Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: echocardiography | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Corvol JC, Anzouan-Kacou JB, Fauveau E, Bonnet AM, Lebrun-Vignes B, Girault C, Agid Y, Lechat P, Isnard R, Lacomblez L. Heart valve regurgitation, pergolide use, and parkinson disease: an observational study and meta-analysis. Arch Neurol. 2007 Dec;64(12):1721-6. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 149 | ||||
| Completion Date | February 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00202657 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 2005-03 | ||||
| Study Sponsor ICMJE | Société Française de Cardiologie | ||||
| Collaborators ICMJE | Institut National de la Santé Et de la Recherche Médicale, France | ||||
| Investigators ICMJE |
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| Information Provided By | Société Française de Cardiologie | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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