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
  Hide Detailed Description

Detailed Description:

Rare incidence of pleuropulmonary and retroperitoneal fibrosis are known complications during the long-time therapy of Parkinson's disease (PD) with ergot-drug derivatives including some ergot dopamine agonists. Particularly the appearance of fibrotic valvular heart disease of Parkinson patients under Pergolide therapy caused an intense discussion about the safety of dopamine agonists at all. Single case reports of similar heart valve changes under the therapy of Bromocriptin and probably Cabergoline pointed to an effect of the whole substance class of the ergot-dopamine agonists.

Cross-Sectional Study (part I):

Within this study an initial cross-sectional analysis of the prevalence of fibrotic heart valvular disease will be done. Patients with Parkinson's disease with different exposition status will be recruited. An transthoracal echocardiographic examination (TTE) of the heart will be performed.

Exposition status:

  • patients with ergot-derived dopamine agonists
  • patients with non-ergot-derived dopamine agonists
  • After the TTE-report the study population is divided in affected (= pathological TTE-report: fibrotic valvular heart diseases) and healthy persons (= non-pathological TTE-report: no fibrotic valvular heart diseases). The therapy with dopamine agonist will be stopped in patients with a pathological TTE-report. Instead these patients will be treated with an equivalent dose of L-Dopa with or without COMT-inhibitors. The existing therapy regime will remain in patients without pathological findings.

Longitudinal Section (part II and III):

The cross-sectional study (part I) is followed by a two year follow-up study.

Cohort I:

  • patients with pathological TTE-report: fibrotic valvular heart disease
  • patients without pathological TTE-report: no fibrotic valvular heart disease

Part II: Within cohort I the reversibility of fibrotic valvular heart disease will be analysed with regard to the previously taken cumulative dose of dopamine agonists.

Part III: Within cohort II there will be a prospective analysis of the (cumulative) incidence of fibrotic valvular heart disease in PD patients with different exposition status. If fibrotic valvular heart disease occurs, a patient will be changed from cohort II to cohort I.

Primary Outcome:

Cross-sectional study (part I):

  • What is the prevalence of fibrotic valvular heart disease in PD patients under therapy with ergot-derived dopamine agonists and non-ergot-derived dopamine agonists?
  • Is there an influence to the cumulative dose of dopamine agonists?

Longitudinal study (prospective cohort study):

  • (Part II) Is fibrotic valvular heart disease under therapy of ergot-derived dopamine agonists and non-ergot-derived dopamine agonists reversible?
  • (Part III) What is the (cumulative) incidence of fibrotic valvular heart disease under the therapy of ergot-derived dopamine agonists and non-ergot-derived dopamine agonists?
  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:
Heart Diseases
Heart Valve Diseases
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Dopamine
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
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014