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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01052948
Other study ID # A7231031
Secondary ID
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


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
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