Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide
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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 |
| 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| France | |
| Clinical Investigation Centre, Pitie-Salpetriere Hospital | |
| Paris, France, 75013 | |
| 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 May 22, 2013