N/A
N=86,939
The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
Parkinson's Disease · Hyperprolactinemia
Bottom Line
View on ClinicalTrials.gov: NCT01052948 ↗Enrolled (actual)
86,939
Serious AEs
—
Results posted
Mar 2011
Primary outcome: Primary: Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up — 21; 21; NA; 52 Participants/10,000 Participant-Years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Retrospective study- (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up |
21; 21; NA; 52 | — |
| PRIMARY Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up |
2; 5; NA; 8 | — |
| PRIMARY Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up |
69; 161; NA; 201 | — |
| PRIMARY Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up |
170; 803; NA; 719 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01052948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.