Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202657
Status:
COMPLETED
Last Update Posted:
2011-12-06
First Post:
2005-09-12
Brief Title:
Observational Study of Heart Valve Disease in Patients With Parkinsons Disease Treated With Pergolide
Sponsor:
Société Française de Cardiologie
Organization:
Société Française de Cardiologie
Study Overview
Official Title:
Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether patients with Parkinsons disease and treated with pergolide have a higher risk of heart valve disease compared to patients with Parkinsons disease not treated with pergolide
Detailed Description:
Pergolide is an ergot dopamine receptor agonist with demonstrated efficacy in Parkinsons 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 Parkinsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None