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The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01052948
First received: January 19, 2010
Last updated: March 17, 2011
Last verified: March 2011
History of Changes
  Purpose

To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:

  1. Cardiac valve regurgitation
  2. Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis
  3. Heart failure
  4. Total, cardiac and respiratory mortality

Condition Intervention
Parkinson's Disease
Hyperprolactinemia
 Other: Retrospective study-

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up [ Time Frame: Up to 12 years ] [ Designated as safety issue: Yes ]
    Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds.

  • Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up [ Time Frame: Up to 12 years ] [ Designated as safety issue: Yes ]
    Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis

  • Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale

  • Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory.


Enrollment: 86939
Study Start Date: January 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort 1
All persons who newly start one of the dopamine agonists (DA) after start of eligibility period
 Other: Retrospective study-
not applicable
Cohort 2
All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior.
 Other: Retrospective study-
not applicable
Cohort 3
All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior.
 Other: Retrospective study-
not applicable
Cohort 4
healthy controls from general population matched on age, gender, index date and general practitioner (GP) practice to persons exposed to dopamine agonists
 Other: Retrospective study-
not applicable

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

General research practice databases or record linkage systems in Europe that provide access to original medical information. These are: The Health Information Network (THIN), Health Search Database (HSD)-THALES, the Integrated Primary Care Information (IPCI) and PHARMO-Record Linkage System (RLS) and meeting criteria for entry into any of the 4 cohorts between 1995 - 2007

Criteria

Inclusion Criteria:

  • At least one year registered with the general practitioner (GP), one year of valid data from the GP, or the date of software conversion (if GP software systems had changed) and meeting criteria for any one of the 4 cohorts as defined.

Exclusion Criteria:

  • rheumatic heart disease
  • congenital heart disease: includes structural defects, congenital arrhythmias, and cardiomyopathies
  • dilated cardiomyopathy (congestive cardiomyopathy
  • pericardial, pleural, pulmonary or retroperitoneal fibrosis
  • endocarditis or myocarditis
  • carcinoid syndrome
  • intravenous drug abuse
  • fibrotic valvular heart disease
  • pleural/pulmonary/pericardial/retroperitoneal fibroses
  • use of fenfluramine or amiodarone within 3 years prior to date of diagnosis of fibrotic valvular heart disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052948

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01052948     History of Changes
Other Study ID Numbers: A7231031
Study First Received: January 19, 2010
Results First Received: December 28, 2010
Last Updated: March 17, 2011
Health Authority: Italy: Societa Italiana Medicina Generale

Keywords provided by Pfizer:
dopamine agonists
cabergoline
Parkinson's disease
 hyperprolactinemia
epidemiology
cardiac valvulopathy

Additional relevant MeSH terms:
Fibrosis
Heart Valve Diseases
Hyperprolactinemia
Parkinson Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Parkinsonian Disorders
 Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Dopamine Agents
Dopamine Agonists
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 19, 2013