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

Study Overview
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Brief Summary
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To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including: Cardiac valve regurgitation Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis Heart failure Total, cardiac and respiratory mortality

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

Conditions
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Parkinson's Disease, Hyperprolactinemia

Intervention / Treatment
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* Other: Retrospective study-
* Other: Retrospective study-
* Other: Retrospective study-
* Other: Retrospective study-


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>All persons who newly start one of the dopamine agonists (DA) after start of eligibility period | Other: Retrospective study-<br> <br> |
| Cohort 2<br>All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior. | Other: Retrospective study-<br> <br> |
| Cohort 3<br>All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior. | Other: Retrospective study-<br> <br> |
| Cohort 4<br>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-<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up | 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. | Up to 12 years | 
| Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up | 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 | Up to 12 years | 
| Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up | Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale | Up to 12 years | 
| Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up | 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. | Up to 12 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dopamine agonists, cabergoline, Parkinson's disease, hyperprolactinemia, epidemiology, cardiac valvulopathy