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Pergolide Treatment and Valvular Heart Disease

Sponsor
Århus Amt (Other)
Overall Status
Completed
CT.gov ID
NCT00234364
Collaborator
(none)
155
Enrollment
1
Location
30
Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In a blinded echocardiographic study we investigate the frequency of valvular abnormalities in a group of Parkinson patients treated with either ergot derived dopamine agonists (pergolide and cabergoline) or non-ergot derived dopamine agonists (pramipexole and ropinirole). The ability to detect patients with valvular abnormalities by clinical approach is examined.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Some case reports and a single study, which included 78 Parkinson patients, has found a correlation between treatment with the ergotamine derivative dopamine agonists (pergolide) and restrictive valvular heart disease. The mechanisms are thought to be the same as with the former used anorectikum, fenfluramine and other drugs stimulating the 5HT-2B receptor.

    In a blinded manner we make physiologic and echocardiographic examination on 160 Parkinson patients treated with either ergotamine or non-ergotamine derivative dopamine agonists (80 patients in each group) to see whether Parkinson patients treated with ergotamine derivatives have more heart valvular disease

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    155 participants
    Observational Model:
    Defined Population
    Time Perspective:
    Other
    Study Start Date :
    Mar 1, 2005
    Actual Study Completion Date :
    Sep 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Parkinson patients who in the last year has been treated minimum 6 months with either ergotamine derivative or non-ergotamine derivative dopamine agonists (the latter included as controls)

      • Informed contests

      Exclusion Criteria:

      • Control patients will be excluded if the have been treated with ergotamine derivates in the last 12 months or if the prior to that have had ergotamine derivates for more than 6 months

      • Patients with known valvular heart disease prior to the diagnosis of Parkinson

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Skejby Hospital Aarhus Aahus N Denmark 8200

      Sponsors and Collaborators

      • Århus Amt

      Investigators

      • Principal Investigator: Vibeke G Rasmussen, MD, Aarhus University Hospital Skejby

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00234364
      Other Study ID Numbers:
      • permax
      First Posted:
      Oct 7, 2005
      Last Update Posted:
      Sep 20, 2007
      Last Verified:
      Sep 1, 2007
      Keywords provided by , ,
      Pergolide
      Ergotamine derivates
      Valvular heart disease
      Additional relevant MeSH terms:
      Parkinson Disease
      Heart Valve Diseases

      Study Results

      No Results Posted as of Sep 20, 2007