Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196898
Status:
UNKNOWN
Last Update Posted:
2012-03-19
First Post:
2005-09-12
Brief Title:
Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinsons Disease Treated With Dopamine Agonists
Sponsor:
German Parkinson Study Group GPS
Organization:
German Parkinson Study Group GPS
Study Overview
Official Title:
A National Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinsons Disease Treated With Dopamine Agonists
Status:
UNKNOWN
Status Verified Date:
2011-04
Last Known Status:
RECRUITING
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:
Fibrotic valvular heart diseases are known as rare complications of long-time therapy of Parkinsons disease with ergot-derivatives including some ergot-dopamine agonists The aim of this study is to assess the incidence of valvular heart disease which may be an ergot-drug agonists side-effect or an overall complication of all dopamine agonists Incidence prevalence and addiction of dose or intake duration are not known so far The reversibility of the changes is unknown too To answer these questions the present study is designed as a cross sectional study followed by a 2 year follow-up prospective cohort study
Detailed Description:
Rare incidence of pleuropulmonary and retroperitoneal fibrosis are known complications during the long-time therapy of Parkinsons disease PD with ergot-drug derivatives including some ergot dopamine agonists Particularly the appearance of fibrotic valvular heart disease of Parkinson patients under Pergolide therapy caused an intense discussion about the safety of dopamine agonists at all Single case reports of similar heart valve changes under the therapy of Bromocriptin and probably Cabergoline pointed to an effect of the whole substance class of the ergot-dopamine agonists
Cross-Sectional Study part I
Within this study an initial cross-sectional analysis of the prevalence of fibrotic heart valvular disease will be done Patients with Parkinsons disease with different exposition status will be recruited An transthoracal echocardiographic examination TTE of the heart will be performed
Exposition status
patients with ergot-derived dopamine agonists
patients with non-ergot-derived dopamine agonists
After the TTE-report the study population is divided in affected pathological TTE-report fibrotic valvular heart diseases and healthy persons non-pathological TTE-report no fibrotic valvular heart diseases The therapy with dopamine agonist will be stopped in patients with a pathological TTE-report Instead these patients will be treated with an equivalent dose of L-Dopa with or without COMT-inhibitors The existing therapy regime will remain in patients without pathological findings
Longitudinal Section part II and III
The cross-sectional study part I is followed by a two year follow-up study
Cohort I
patients with pathological TTE-report fibrotic valvular heart disease
patients without pathological TTE-report no fibrotic valvular heart disease
Part II Within cohort I the reversibility of fibrotic valvular heart disease will be analysed with regard to the previously taken cumulative dose of dopamine agonists
Part III Within cohort II there will be a prospective analysis of the cumulative incidence of fibrotic valvular heart disease in PD patients with different exposition status If fibrotic valvular heart disease occurs a patient will be changed from cohort II to cohort I
Primary Outcome
Cross-sectional study part I
What is the prevalence of fibrotic valvular heart disease in PD patients under therapy with ergot-derived dopamine agonists and non-ergot-derived dopamine agonists
Is there an influence to the cumulative dose of dopamine agonists
Longitudinal study prospective cohort study
Part II Is fibrotic valvular heart disease under therapy of ergot-derived dopamine agonists and non-ergot-derived dopamine agonists reversible
Part III What is the cumulative incidence of fibrotic valvular heart disease under the therapy of ergot-derived dopamine agonists and non-ergot-derived dopamine agonists
Cross-Sectional Study part I
Within this study an initial cross-sectional analysis of the prevalence of fibrotic heart valvular disease will be done Patients with Parkinsons disease with different exposition status will be recruited An transthoracal echocardiographic examination TTE of the heart will be performed
Exposition status
patients with ergot-derived dopamine agonists
patients with non-ergot-derived dopamine agonists
After the TTE-report the study population is divided in affected pathological TTE-report fibrotic valvular heart diseases and healthy persons non-pathological TTE-report no fibrotic valvular heart diseases The therapy with dopamine agonist will be stopped in patients with a pathological TTE-report Instead these patients will be treated with an equivalent dose of L-Dopa with or without COMT-inhibitors The existing therapy regime will remain in patients without pathological findings
Longitudinal Section part II and III
The cross-sectional study part I is followed by a two year follow-up study
Cohort I
patients with pathological TTE-report fibrotic valvular heart disease
patients without pathological TTE-report no fibrotic valvular heart disease
Part II Within cohort I the reversibility of fibrotic valvular heart disease will be analysed with regard to the previously taken cumulative dose of dopamine agonists
Part III Within cohort II there will be a prospective analysis of the cumulative incidence of fibrotic valvular heart disease in PD patients with different exposition status If fibrotic valvular heart disease occurs a patient will be changed from cohort II to cohort I
Primary Outcome
Cross-sectional study part I
What is the prevalence of fibrotic valvular heart disease in PD patients under therapy with ergot-derived dopamine agonists and non-ergot-derived dopamine agonists
Is there an influence to the cumulative dose of dopamine agonists
Longitudinal study prospective cohort study
Part II Is fibrotic valvular heart disease under therapy of ergot-derived dopamine agonists and non-ergot-derived dopamine agonists reversible
Part III What is the cumulative incidence of fibrotic valvular heart disease under the therapy of ergot-derived dopamine agonists and non-ergot-derived dopamine agonists
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Grant 01 GI 020101 GI 0401 | None | None | None |