Heart FailureNCT02236741
The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia
An observational study of Heart Failure, run by Boehringer Ingelheim.
Trial summary
Study to assess the risk of incident heart failure associated with the use of pramipexole compared with other dopamine agonists and additionally, to assess the risk of incident heart failure associated with the use of dopamine agonists in comparison with no use of dopamine agonist therapy Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Mirapexin® (Sifrol®)
- How many people
- 26,814 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Users of anti-parkinsonian drugs registered with an up-to-standard practice from the United Kingdom's General Practice Research Database (GPRD)
Who may be able to join
- All patients between 40 and 89 years of age who received at least one prescription for anti-parkinsonian drugs during the period 1997-2009
Who cannot join
- Patients with a diagnosis of heart failure or with prescriptions for two or more among the digitalis, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blocker (ARB), and diuretic drug classes prior to cohort entry
About this study
Study to assess the risk of incident heart failure associated with the use of pramipexole compared with other dopamine agonists and additionally, to assess the risk of incident heart failure associated with the use of dopamine agonists in comparison with no use of dopamine agonist therapy
- Conditions
- Heart Failure
- Being tested
- Mirapexin® (Sifrol®)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirapexin® (Sifrol®)Drug
| Study group | Role | What they receive |
|---|---|---|
| users of anti-parkinsonian drugs | Not described Receives: Drug: Mirapexin® (Sifrol®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of first-time clinical diagnosis of heart failure
Measured: 150 months
Secondary outcomes (1)
Overall rate of heart failure
Measured: 150 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startNov 2009
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- 26,814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236741
- Sponsor's protocol ID
- 248.672
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia
- ClinicalTrials.gov ID
- NCT02236741
- Acronym / sponsor ID
- 248.672
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,814 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to assess the risk of incident heart failure associated with the use of pramipexole compared with other dopamine agonists and additionally, to assess the risk of incident heart failure associated with the use of dopamine agonists in comparison with no use of dopamine agonist therapy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| users of anti-parkinsonian drugs | – | Drug: Mirapexin® (Sifrol®) |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Users of anti-parkinsonian drugs registered with an up-to-standard practice from the United Kingdom's General Practice Research Database (GPRD)
Key inclusion criteria (1 listed)
- All patients between 40 and 89 years of age who received at least one prescription for anti-parkinsonian drugs during the period 1997-2009
Key exclusion criteria (1 listed)
- Patients with a diagnosis of heart failure or with prescriptions for two or more among the digitalis, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blocker (ARB), and diuretic drug classes prior to cohort entry
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 |
|---|---|---|
| Mirapexin® (Sifrol®) | Drug | users of anti-parkinsonian drugs |
Primary outcome
Assessment of first-time clinical diagnosis of heart failure
Time frame: 150 months
1 secondary outcome
Overall rate of heart failure
Time frame: 150 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Boehringer Ingelheim.
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 1 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 11 Sep 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of first-time clinical diagnosis of heart failure (time frame: 150 months). 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 11 Sep 2014.