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

NCT01052948

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson's Disease, Hyperprolactinemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
Official Title The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
Brief Summary

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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Parkinson's Disease
  • Hyperprolactinemia
Intervention Other: Retrospective study-
Study Groups/Cohorts
  • Cohort 1
    All persons who newly start one of the dopamine agonists (DA) after start of eligibility period
    Intervention: Other: Retrospective study-
  • Cohort 2
    All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior.
    Intervention: Other: Retrospective study-
  • Cohort 3
    All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior.
    Intervention: Other: Retrospective study-
  • Cohort 4
    healthy controls from general population matched on age, gender, index date and general practitioner (GP) practice to persons exposed to dopamine agonists
    Intervention: Other: Retrospective study-
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 25, 2010)
86939
Original Actual Enrollment
 (submitted: January 19, 2010)
57628
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01052948
Other Study ID Numbers A7231031
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2011