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...
Date First Received: October 4, 2005
Last Updated: September 19, 2007
Verified by: Århus Amt, September 2007
Clinical Trial Phase: N/A | Start Date: March 2005
Overall Status: Completed
Estimated Enrollment: 155
Brief Summary
Condition Keyword(s):
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.
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Detailed Clinical Trial 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Århus Amt
Overall Clinical Trial Officials and Contacts
Vibeke G Rasmussen, MD Principal Investigator Skejby Hospital
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234364
Study ID Number: permax
ClinicalTrials.gov Identifier: NCT00234364
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Clinical Trials Authorship and Review
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