Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinson's Disease Treated With Dopamine Agonists
This study is currently recruiting participants.
Verified April 2011 by German Parkinson Study Group (GPS)
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
First received: September 12, 2005
Last updated: March 16, 2012
Last verified: April 2011
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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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial paroxysmal nonkinesigenic dyskinesia
Perry syndrome
U.S. FDA Resources
Further study details as provided by German Parkinson Study Group (GPS):
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | December 2013 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
No publications provided
| 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 16, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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:
|
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 |
ClinicalTrials.gov processed this record on October 16, 2012
