Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinson's Disease Treated With Dopamine Agonists
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|ClinicalTrials.gov Identifier: NCT00196898|
Recruitment Status : Unknown
Verified April 2011 by German Parkinson Study Group (GPS).
Recruitment status was: Recruiting
First Posted : September 20, 2005
Last Update Posted : March 19, 2012
|First Submitted Date||September 12, 2005|
|First Posted Date||September 20, 2005|
|Last Update Posted Date||March 19, 2012|
|Study Start Date||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00196898 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinson's Disease Treated With Dopamine Agonists|
|Official Title||A National, Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinson´s Disease Treated With Dopamine Agonists|
|Brief Summary||Fibrotic valvular heart diseases are known as rare complications of long-time therapy of Parkinson's 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.|
Rare incidence of pleuropulmonary and retroperitoneal fibrosis are known complications during the long-time therapy of Parkinson's 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 Parkinson's disease with different exposition status will be recruited. An transthoracal echocardiographic examination (TTE) of the heart will be performed.
Longitudinal Section (part II and III):
The cross-sectional study (part I) is followed by a two year follow-up study.
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.
Cross-sectional study (part I):
Longitudinal study (prospective cohort study):
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||PD Patients|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status||Unknown status|
|Estimated Study Completion Date||December 2013|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Germany|
|Removed Location Countries|
|Other Study ID Numbers||1.0 / 03.02.05
Grant 01 GI 0201/01 GI 0401
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Competence Network on Parkinson´s disease, Dr. Karla Eggert, Competence Network on Parkinson´s disease|
|Study Sponsor||German Parkinson Study Group (GPS)|
|Collaborators||Competence Network on Parkinson's Disease|
|PRS Account||German Parkinson Study Group (GPS)|
|Verification Date||April 2011|