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

Completed

• Conditions: Parkinson's Disease; Hyperprolactinemia
• Interventions: Other: Retrospective study-

• Registration Number: NCT01052948
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-21
• Results First Submitted: 2010-12-28
• Results First Submitted QC: 2011-02-15
• Status Verified: 2011-03
• Results First Posted: 2011-03-11
• Last Update Submitted: 2011-03-17
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86939

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Retrospective study-	All persons who newly start one of the dopamine agonists (DA) after start of eligibility period
Cohort 2	Retrospective study-	All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior.
Cohort 3	Retrospective study-	All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior.
Cohort 4	Retrospective study-	healthy controls from general population matched on age, gender, index date and general practitioner (GP) practice to persons exposed to dopamine agonists

Primary Outcome Measures

Name	Time	Method
Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up	Up to 12 years	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	Up to 12 years	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	Up to 12 years	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	Up to 12 years	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.