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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052948
• Other study ID #: A7231031
• Status: Completed
• Phase: N/A
• First received: January 19, 2010
• Last updated: March 17, 2011
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Societa Italiana Medicina Generale
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86939
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Valve Diseases
• Hyperprolactinemia
• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Retrospective study-

• Retrospective study-

• Retrospective study-

• Retrospective study-

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	No
Primary	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	No

External Links

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