The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 86,939
- 主要终点
- Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点