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| Sponsor: | German Parkinson Study Group (GPS) |
|---|---|
| Collaborator: |
Competence Network on Parkinson's Disease |
| Information provided by: | German Parkinson Study Group (GPS) |
| ClinicalTrials.gov Identifier: | NCT00196898 |
Purpose
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 |
|---|
|
Heart Valve Diseases Parkinson's Disease |
| Study Type: | Observational |
| Study Design: | 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | April 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| 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 |
More Information
| 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 |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 25, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Parkinson´s disease fibrotic valvular heart fibrosis ergot dopamine agonists non-ergot dopamine agonists |
|
Heart Diseases Heart Valve Diseases Parkinson Disease Cardiovascular Diseases Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Dopamine Dopamine Agents |
Dopamine Agonists Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |