NCT00196898

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
8.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 19, 2012

Status Verified

April 1, 2011

First QC Date

September 12, 2005

Last Update Submit

March 16, 2012

Conditions

Heart Valve DiseasesParkinson's Disease

Keywords

Parkinson´s diseasefibrotic valvular heart fibrosisergot dopamine agonistsnon-ergot dopamine agonists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PD Patients

You may qualify if:

  • Age \> 18 years
  • Diagnosis of Morbus Parkinson
  • Written informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Marburg und Gießen, Neurologische Klinik

Marburg, Hesse, 35033, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

Heart Valve DiseasesParkinson Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Wolfgang Oertel, Prof. Dr.

    Universitätsklinikum Marburg und Gießen

    STUDY CHAIR

Central Study Contacts

Karla Eggert, Dr.

CONTACT

+49 (0)6421 2865443eggert@med.uni-marburg.de

Wolfgang M. Oertel, Prof. Dr.

CONTACT

+49 (0) 6421 866278oertelw@med.uni-marburg.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2005

Study Completion

December 1, 2013

Last Updated

March 19, 2012

Record last verified: 2011-04

Locations

DE(1)