Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinson's Disease Treated With Dopamine Agonists

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Homepage Competence Network on Parkinson`s disease sponsored by the German government 

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
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