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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
Sponsor:
Collaborator:
Competence Network on Parkinson's Disease
Information provided by:
German Parkinson Study Group (GPS)

Study Description
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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.

Condition or disease
Heart Valve Diseases Parkinson's Disease

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Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National, Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinson´s Disease Treated With Dopamine Agonists
Study Start Date : March 2005
Estimated Study Completion Date : December 2013

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PD Patients
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Diagnosis of Morbus Parkinson
  • Written informed consent

Exclusion Criteria:

  • Patients with a history of carcinoid syndrome
  • Patients with a history of post-inflammatory (rheumatic), degenerative (calcified) or ischaemic coronary heart or valvular heart disease
  • Previous medication with ergot-derived drugs (eg. Methysergide, Ergotamine) except dopamine receptor agonists or anorectic drugs (eg. Fenfluramine, Dexfenfluramine)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196898


Contacts
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

Locations
Germany
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.         
Sponsors and Collaborators
German Parkinson Study Group (GPS)
Competence Network on Parkinson's Disease
Investigators
Study Chair: Wolfgang Oertel, Prof. Dr. Universitätsklinikum Marburg und Gießen
More Information
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Additional Information:
Homepage Competence Network on Parkinson`s disease sponsored by the German government  This link exits the ClinicalTrials.gov site

Responsible Party: Competence Network on Parkinson´s disease, Dr. Karla Eggert, Competence Network on Parkinson´s disease
ClinicalTrials.gov Identifier: NCT00196898     History of Changes
Other Study ID Numbers: 1.0 / 03.02.05
Grant 01 GI 0201/01 GI 0401
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: April 2011

Keywords provided by German Parkinson Study Group (GPS):
Parkinson´s disease
fibrotic valvular heart fibrosis
ergot dopamine agonists
non-ergot dopamine agonists

Additional relevant MeSH terms:
Parkinson Disease
Heart Diseases
Heart Valve Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cardiovascular Diseases
 Dopamine
Dopamine Agents
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents