Parkinson's DiseaseNCT01052948
The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
An observational study of Parkinson's Disease and Hyperprolactinemia, run by Pfizer.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease, Hyperprolactinemia
- What is being tested?
- Retrospective study-
- How many people
- 86,939 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:
- Cardiac valve regurgitation
- Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis
- Heart failure
- Total, cardiac and respiratory mortality
- Conditions
- Parkinson's Disease, Hyperprolactinemia
- Being tested
- Retrospective study-
- Keywords
- dopamine agonists, cabergoline, Parkinson's disease, hyperprolactinemia, epidemiology, cardiac valvulopathy
- Medical subject headings
- Parkinson Disease, Hyperprolactinemia, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective study-Other
Retrospective study-Other
Retrospective study-Other
Retrospective study-Other
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | All persons who newly start one of the dopamine agonists (DA) after start of eligibility period Receives: 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. Receives: Other: Retrospective study- | |
| Cohort 3 | All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior. Receives: 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 Receives: Other: Retrospective study- |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86,939 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052948
- Sponsor's protocol ID
- A7231031
- Status last verified
- Mar 2011
- First submitted
- 19 Jan 2010
- Last updated
- 23 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
- ClinicalTrials.gov ID
- NCT01052948
- Acronym / sponsor ID
- A7231031
- Conditions
- Parkinson's Disease, Hyperprolactinemia
- Keywords
- dopamine agonists, cabergoline, Parkinson's disease, hyperprolactinemia, epidemiology, cardiac valvulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86,939 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Posted 11 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:
- Cardiac valve regurgitation
- Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis
- Heart failure
- Total, cardiac and respiratory mortality
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Retrospective study-All persons who newly start one of the dopamine agonists (DA) after start of eligibility period |
| Cohort 2 | – | Other: Retrospective study-All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior. |
| Cohort 3 | – | Other: Retrospective study-All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior. |
| Cohort 4 | – | Other: Retrospective study-healthy controls from general population matched on age, gender, index date and general practitioner (GP) practice to persons exposed to dopamine agonists |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective study- | Other | Cohort 1 |
| Retrospective study- | Other | Cohort 2 |
| Retrospective study- | Other | Cohort 3 |
| Retrospective study- | Other | Cohort 4 |
Primary outcome
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.
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Hyperprolactinemia, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up (time frame: Up to 12 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011.