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Pergolide Treatment and Valvular Heart Disease

This study has been completed.
Sponsor:
Information provided by:
Århus Amt
ClinicalTrials.gov Identifier:
NCT00234364
First received: October 4, 2005
Last updated: September 19, 2007
Last verified: September 2007
History of Changes
  Purpose

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.


Condition
Heart Valve Diseases
Parkinson's Disease
Pergolide
Fibrosis

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Århus Amt:

Enrollment: 155
Study Start Date: March 2005
Study Completion Date: September 2007
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234364

Locations
Denmark
Skejby Hospital
Aarhus, Aahus N, Denmark, 8200
Sponsors and Collaborators
Århus Amt
Investigators
Principal Investigator: Vibeke G Rasmussen, MD Skejby Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234364     History of Changes
Other Study ID Numbers: permax
Study First Received: October 4, 2005
Last Updated: September 19, 2007
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Århus Amt:
Pergolide
Ergotamine derivates
Valvular heart disease

Additional relevant MeSH terms:
Fibrosis
Heart Diseases
Heart Valve Diseases
Parkinson Disease
Pathologic Processes
Cardiovascular Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pergolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013