Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234364
Status:
COMPLETED
Last Update Posted:
2007-09-20
First Post:
2005-10-04
Brief Title:
Pergolide Treatment and Valvular Heart Disease
Sponsor:
Århus Amt
Organization:
Århus Amt
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-09
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:
In a blinded echocardiographic study we investigate the frequency of valvular abnormalities in a group of Parkinson patients treated with either ergot derived dopamine agonists pergolide and cabergoline or non-ergot derived dopamine agonists pramipexole and ropinirole The ability to detect patients with valvular abnormalities by clinical approach is examined
Detailed Description:
Some case reports and a single study which included 78 Parkinson patients has found a correlation between treatment with the ergotamine derivative dopamine agonists pergolide and restrictive valvular heart disease The mechanisms are thought to be the same as with the former used anorectikum fenfluramine and other drugs stimulating the 5HT-2B receptor
In a blinded manner we make physiologic and echocardiographic examination on 160 Parkinson patients treated with either ergotamine or non-ergotamine derivative dopamine agonists 80 patients in each group to see whether Parkinson patients treated with ergotamine derivatives have more heart valvular disease
In a blinded manner we make physiologic and echocardiographic examination on 160 Parkinson patients treated with either ergotamine or non-ergotamine derivative dopamine agonists 80 patients in each group to see whether Parkinson patients treated with ergotamine derivatives have more heart valvular disease
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