- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202657
Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide
December 5, 2011 updated by: Société Française de Cardiologie
Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
149
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75013
- Clinical Investigation Centre, Pitie-Salpetriere Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients treated with Pergolide for Parkinson disease or Patients with parkinson disease not treated with Pergolide
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Christophe CORVOL, MD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Completion
February 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
December 6, 2011
Last Update Submitted That Met QC Criteria
December 5, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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