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

March 16, 2012 updated by: German Parkinson Study Group (GPS)

A National, Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinson´s Disease Treated With Dopamine Agonists

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.

Study Overview

Status

Unknown

Conditions

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?

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Hessen
      • Marburg, Hessen, Germany, 35033
        • Recruiting
        • Universitätsklinikum Marburg und Gießen, Neurologische Klinik
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wolfgang H. Oertel, Prof. Dr.
        • Principal Investigator:
          • Karla M Eggert, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

PD Patients

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Parkinson Study Group (GPS)

Collaborators

Competence Network on Parkinson's Disease

Investigators

  • Study Chair: Wolfgang Oertel, Prof. Dr., Universitätsklinikum Marburg und Gießen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0 / 03.02.05
  • Grant 01 GI 0201/01 GI 0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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