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OpenTrials
Completed

NCT Number: NCT01052948

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

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Endocrine System Diseases Heart Diseases Heart Valve Diseases Hyperpituitarism Hyperprolactinemia Hypothalamic Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Pituitary Diseases Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective study-

Other

Primary outcomes

  1. Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up

    Time frame: 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.

  2. Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up

    Time frame: 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

  3. Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up

    Time frame: Up to 12 years

    Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale

  4. Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 21, 2010
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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