Pergolide Treatment and Valvular Heart Disease

Completed

• Conditions: Heart Valve Diseases; Parkinson's Disease; Pergolide; Fibrosis

• Registration Number: NCT00234364
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-07
• Status Verified: 2007-09
• Study Completion: 2007-09
• Last Update Submitted: 2007-09-19
• Last Update Posted: 2007-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Skejby Hospital; 🇩🇰 Aarhus, Aahus N, Denmark