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Sponsors and Collaborators: |
German Parkinson Study Group (GPS) Competence Network on Parkinson`s disease |
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Information provided by: | German Parkinson Study Group (GPS) |
ClinicalTrials.gov Identifier: | NCT00196898 |
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.
Condition |
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Heart Valve Diseases Parkinson's Disease |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A National, Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinson´s Disease Treated With Dopamine Agonists |
Estimated Enrollment: | 100 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | April 2007 |
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):
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karla Eggert, Dr. | +49 (0)6421 2865443 | eggert@med.uni-marburg.de |
Contact: Wolfgang M. Oertel, Prof. Dr. | +49 (0) 6421 866278 | oertelw@med.uni-marburg.de |
Germany, Hessen | |
Universitätsklinikum Marburg und Gießen, Neurologische Klinik | Recruiting |
Marburg, Hessen, Germany, 35033 | |
Contact: Wolfgang H. Oertel, Prof. Dr. + 49 6421- 28 66278 oertelw@med.uni-marburg.de | |
Contact: Karla M. Eggert, Dr. + 49 6421- 28 65443 eggert@med.uni-marburg | |
Principal Investigator: Wolfgang H. Oertel, Prof. Dr. | |
Principal Investigator: Karla M Eggert, Dr. |
Study Chair: | Wolfgang Oertel, Prof. Dr. | Universitätsklinikum Marburg und Gießen |
Responsible Party: | Competence Network on Parkinson´s disease ( Competence Network on Parkinson´s disease, Dr. Karla Eggert ) |
Study ID Numbers: | 1.0 / 03.02.05, Grant 01 GI 0201/01 GI 0401 |
Study First Received: | September 12, 2005 |
Last Updated: | March 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00196898 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Parkinson´s disease fibrotic valvular heart fibrosis ergot dopamine agonists non-ergot dopamine agonists |
Dopamine Ganglion Cysts Heart Diseases Movement Disorders Fibrosis Parkinson Disease |
Basal Ganglia Diseases Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Heart Valve Diseases |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Sympathomimetics Nervous System Diseases Physiological Effects of Drugs Cardiovascular Agents |
Protective Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Cardiovascular Diseases Dopamine Agents Peripheral Nervous System Agents |