An observational study in Heart Valve Diseases and Parkinson's Disease, sponsored by German Parkinson Study Group (GPS). Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-19.
Sponsored by German Parkinson Study Group (GPS) · Observational
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.
Exposition status:
Longitudinal Section (part II and III):
The cross-sectional study (part I) is followed by a two year follow-up study.
Cohort I:
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):
Longitudinal study (prospective cohort study):
544 studies on the registry are indexed under Heart Valve Diseases; 174 are open to participants now.
This study's planned enrollment of 100 is below the median of 300 across 235 observational studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →German Parkinson Study Group (GPS) is the lead sponsor of 7 studies on the registry; none are open to participants now.
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PD Patients
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Exclusion Criteria:
This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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German Parkinson Study Group (GPS)