Atrial FibrillationPhase 4NCT00783900
Intravenous Administration of Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery
A Phase 4 study testing metoprolol, biatrial pacing in people with Atrial Fibrillation and Biatrial Pacing, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Biatrial Pacing, Metoprolol
- What is being tested?
- metoprolol, biatrial pacing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2007to Dec 2009
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- elective CABG and aortic valve cardiac patients,
- previous use of beta blocker
Who cannot join
- Previous episodes of Atrial fibrillation or flutter,
- II or II degree atrioventricular block, uncontrolled heart failure
- Sick sinus syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery
The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery
- Conditions
- Atrial Fibrillation, Biatrial Pacing, Metoprolol
- Being tested
- metoprolol, biatrial pacing
- Keywords
- Prevention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoprolol, biatrial pacingOther
Prevention, atrial fibrillation, cardiac surgery, biatrial pacing, metoprolol
| Study group | Role | What they receive |
|---|---|---|
| metoprolol | Active comparator | Not described Receives: Other: metoprolol, biatrial pacing |
| biatrial pacing | Active comparator | Not described Receives: Other: metoprolol, biatrial pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
biatriac pacing
Measured: 48 hours
Incidence of atrial fibrillation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (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.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital, Hospital Cordia, Kuopio, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783900
- Sponsor's protocol ID
- KUH5204006
- Other IDs
- Eudra-CT: 2008-006932-36
- Status last verified
- Nov 2011
- First submitted
- 31 Oct 2008
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00783900
- Acronym / sponsor ID
- KUH5204006
- Conditions
- Atrial Fibrillation, Biatrial Pacing, Metoprolol
- Keywords
- Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Oulu University Hospital, Hospital Cordia, Kuopio, Finland
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Nov 2008 (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.
The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metoprolol | Active comparator | Other: metoprolol, biatrial pacing |
| biatrial pacing | Active comparator | Other: metoprolol, biatrial pacing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- elective CABG and aortic valve cardiac patients,
- previous use of beta blocker
Key exclusion criteria (3 listed)
- Previous episodes of Atrial fibrillation or flutter,
- II or II degree atrioventricular block, uncontrolled heart failure
- Sick sinus syndrome
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 |
|---|---|---|
| metoprolol, biatrial pacingPrevention, atrial fibrillation, cardiac surgery, biatrial pacing, metoprolol | Other | biatrial pacing, metoprolol |
Primary outcome
biatriac pacing
Time frame: 48 hours
Incidence of atrial fibrillation
Time frame: 48 hours
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 3 Mar 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metoprolol, biatrial pacing in people with Atrial Fibrillation and Biatrial Pacing, run by Kuopio University Hospital at 1 site in Finland.
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 2 inclusion and 3 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
biatriac pacing (time frame: 48 hours). The study lists 2 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 3 Mar 2017.