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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 groups in NCT01052948
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.

Jan 2007Dec 2009

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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

Results posted to the registry on 11 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dopamine Agonist (Cohort 1)	27,812	27,812
Levodopa (Cohort 2)	14,669	14,669
Hyperprolactinemia (Cohort 3)	15,147	15,147
Healthy Controls (Cohort 4)	29,311	29,311

Primary outcome: Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up

Time frame: Up to 12 years. Number. Unit: Participants/10,000 Participant-Years

Measure	Dopamine Agonist (Cohort 1) n = 27812	Levodopa (Cohort 2) n = 14669	Hyperprolactinemia (Cohort 3) n = 15147	Healthy Controls (Cohort 4) n = 29311
Value	21	21	NA	52

Population analysed: Per protocol.

Primary outcome: Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up

Time frame: Up to 12 years. Number. Unit: Participants/10,000 Participant-Years

Measure	Dopamine Agonist (Cohort 1) n = 27812	Levodopa (Cohort 2) n = 14669	Hyperprolactinemia (Cohort 3) n = 15147	Healthy Controls (Cohort 4) n = 29311
Value	2	5	NA	8

Population analysed: Per protocol.

Primary outcome: Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up

Time frame: Up to 12 years. Number. Unit: Participants/10,000 Participant-Years

Measure	Dopamine Agonist (Cohort 1) n = 27812	Levodopa (Cohort 2) n = 14669	Hyperprolactinemia (Cohort 3) n = 15147	Healthy Controls (Cohort 4) n = 29311
Value	69	161	NA	201

Population analysed: Per protocol.

Primary outcome: Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up

Time frame: Up to 12 years. Number. Unit: Participants/10,000 Participant-Years

Measure	Dopamine Agonist (Cohort 1) n = 27812	Levodopa (Cohort 2) n = 14669	Hyperprolactinemia (Cohort 3) n = 15147	Healthy Controls (Cohort 4) n = 29311
Value	170	803	NA	719

Population analysed: Per protocol.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dopamine Agonist (Cohort 1)	0 of 0	0 of 0	Not reported
Levodopa (Cohort 2)	0 of 0	0 of 0	Not reported
Hyperprolactinemia (Cohort 3)	0 of 0	0 of 0	Not reported
Healthy Controls (Cohort 4)	0 of 0	0 of 0	Not reported

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?

On the ClinicalTrials.gov record for NCT01052948.

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; AzTrials last refreshed its copy on 8 Nov 2026.