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Pergolide Treatment and Valvular Heart Disease
This study has been completed.
Study NCT00234364   Information provided by Århus Amt
First Received: October 4, 2005   Last Updated: September 19, 2007   History of Changes

October 4, 2005
September 19, 2007
March 2005
 
 
 
Complete list of historical versions of study NCT00234364 on ClinicalTrials.gov Archive Site
 
 
 
Pergolide Treatment and Valvular Heart Disease
 

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.

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

 
Observational
Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
  • Heart Valve Diseases
  • Parkinson's Disease
  • Pergolide
  • Fibrosis
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
155
September 2007
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00234364
 
permax
Århus Amt
 
Principal Investigator: Vibeke G Rasmussen, MD Skejby Hospital
Århus Amt
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP