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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by German Parkinson Study Group (GPS).
Recruitment status was  Recruiting
Competence Network on Parkinson's Disease
Information provided by:
German Parkinson Study Group (GPS) Identifier:
First received: September 12, 2005
Last updated: March 16, 2012
Last verified: April 2011

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.

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:

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


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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00196898

Contact: Karla Eggert, Dr. +49 (0)6421 2865443
Contact: Wolfgang M. Oertel, Prof. Dr. +49 (0) 6421 866278

Universitätsklinikum Marburg und Gießen, Neurologische Klinik Recruiting
Marburg, Hessen, Germany, 35033
Contact: Wolfgang H. Oertel, Prof. Dr.    + 49 6421- 28 66278   
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
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 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 Valve Diseases
Heart Diseases
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Dopamine Agents
Dopamine Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on October 08, 2015