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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.
Full description
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):
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Central trial contact
Wolfgang M. Oertel, Prof. Dr.; Karla Eggert, Dr.
Data sourced from clinicaltrials.gov
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