Pergolide Treatment and Valvular Heart Disease

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234364
• Other study ID #: permax
• Status: Completed
• Phase: N/A
• First received: October 4, 2005
• Last updated: September 19, 2007
• Start date: March 2005
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: Århus Amt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fibrosis
• Heart Valve Diseases
• Parkinson Disease
• Parkinson's Disease
• Pergolide

Locations

Country	Name	City	State
Denmark	Skejby Hospital	Aarhus	Aahus N

Sponsors (1)

Lead Sponsor	Collaborator
Århus Amt

Country where clinical trial is conducted

Denmark,