Pergolide Treatment and Valvular Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Heart Valve Diseases Parkinson's Disease Pergolide Fibrosis

Keywords

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Pergolide Ergotamine derivates Valvular heart disease

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Vibeke G Rasmussen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital Skejby

Locations

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Skejby Hospital

Aarhus, Aahus N, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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permax

Identifier Type: -

Identifier Source: org_study_id