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
Sponsor:
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
  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:


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
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 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:
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
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 01, 2014