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Pergolide Treatment and Valvular Heart Disease

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ClinicalTrials.gov Identifier: NCT00234364
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : September 20, 2007
Sponsor:
Information provided by:
Århus Amt

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
Heart Valve Diseases Parkinson's Disease Pergolide Fibrosis

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 Type : Observational
Actual Enrollment : 155 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Study Start Date : March 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Pergolide
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234364


Locations
Denmark
Skejby Hospital
Aarhus, Aahus N, Denmark, 8200
Sponsors and Collaborators
Århus Amt
Investigators
Principal Investigator: Vibeke G Rasmussen, MD Aarhus University Hospital Skejby

ClinicalTrials.gov Identifier: NCT00234364     History of Changes
Other Study ID Numbers: permax
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: September 20, 2007
Last Verified: September 2007

Keywords provided by Århus Amt:
Pergolide
Ergotamine derivates
Valvular heart disease

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
Pergolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs