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

NCT01052948 | Completed Results DMC

• 1 other identifier: A7231031
• Study Type: observational
• Target: 86,939
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:

1. 1.Cardiac valve regurgitation
2. 2.Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis
3. 3.Heart failure
4. 4.Total, cardiac and respiratory mortality

Conditions

Parkinson's Disease; Hyperprolactinemia

Keywords

dopamine agonists; cabergoline; Parkinson's disease; hyperprolactinemia; epidemiology; cardiac valvulopathy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Cohort 1

All persons who newly start one of the dopamine agonists (DA) after start of eligibility period

Other: Retrospective study-

Cohort 2

All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior.

Other: Retrospective study-

Cohort 3

All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior.

Other: Retrospective study-

Cohort 4

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-

Interventions

Retrospective study- OTHER

Cohort 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General research practice databases or record linkage systems in Europe that provide access to original medical information. These are: The Health Information Network (THIN), Health Search Database (HSD)-THALES, the Integrated Primary Care Information (IPCI) and PHARMO-Record Linkage System (RLS) and meeting criteria for entry into any of the 4 cohorts between 1995 - 2007

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Parkinson Disease; Hyperprolactinemia; Heart Valve Diseases

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: January 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 23, 2011
• Results First Posted: March 11, 2011

Record last verified: 2011-03