Atrial FibrillationPhase 4NCT00784316
Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
A Phase 4 study testing metoprolol, amiodarone in people with Atrial Fibrillation and Cardiac Surgery, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The aim of the study is to test the efficiency of intravenous administration of metoprolol versus intravenous administration of amiodarone 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, Cardiac Surgery
- What is being tested?
- metoprolol, amiodarone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2007to Jul 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 patients in cardiac surgery,
- previous use of betablocker therapy
Who cannot join
- previous atrial fibrillation or flutter,
- thyroid disease,
- uncontrolled heart failure,
- II or III degree atrioventricular block
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to test the efficiency of intravenous administration of metoprolol versus intravenous administration of amiodarone in the prevention of atrial fibrillation after cardiac surgery.
- Conditions
- Atrial Fibrillation, Cardiac Surgery
- Being tested
- metoprolol, amiodarone
- 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, amiodaroneDrug
to compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| metoprolol | Active comparator | Not described Receives: Drug: metoprolol, amiodarone |
| amiodarone | Active comparator | Not described Receives: Drug: metoprolol, amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 startAug 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Tampere University Hospital, Vaasa Central Hospital, Vaasa, Finland
- Responsible party
- Principal investigator, Jari Halonen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784316
- Sponsor's protocol ID
- KUH5204005
- Status last verified
- Nov 2011
- First submitted
- 31 Oct 2008
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Halonen J, Loponen P, Jarvinen O, Karjalainen J, Parviainen I, Halonen P, Magga J, Turpeinen A, Hippelainen M, Hartikainen J, Hakala T. Metoprolol versus amiodarone in the prevention of atrial fibrillation after cardiac surgery: a randomized trial. Ann Intern Med. 2010 Dec 7;153(11):703-9. doi: 10.7326/0003-4819-153-11-201012070-00003.
PubMed 21135293
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00784316
- Acronym / sponsor ID
- KUH5204005
- Conditions
- Atrial Fibrillation, Cardiac Surgery
- Keywords
- Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Vaasa Central Hospital, Vaasa, Finland
- Study start
- Aug 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 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 test the efficiency of intravenous administration of metoprolol versus intravenous administration of amiodarone 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 | Drug: metoprolol, amiodarone |
| amiodarone | Active comparator | Drug: metoprolol, amiodarone |
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 patients in cardiac surgery,
- previous use of betablocker therapy
Key exclusion criteria (4 listed)
- previous atrial fibrillation or flutter,
- thyroid disease,
- uncontrolled heart failure,
- II or III degree atrioventricular block
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, amiodaroneto compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery | Drug | amiodarone, metoprolol |
Primary outcome
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 24 Nov 2011.
- Derived from this study: PubMed 21135293Halonen J, Loponen P, Jarvinen O, Karjalainen J, Parviainen I, Halonen P, Magga J, Turpeinen A, Hippelainen M, Hartikainen J, Hakala T. Metoprolol versus amiodarone in the prevention of atrial fibrillation after cardiac surgery: a randomized trial. Ann Intern Med. 2010 Dec 7;153(11):703-9. doi: 10.7326/0003-4819-153-11-201012070-00003.
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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, amiodarone in people with Atrial Fibrillation and Cardiac Surgery, 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 4 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 24 Nov 2011. 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?
Incidence of atrial fibrillation (time frame: 48 hours). 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 NCT00784316, which also lists 1 linked publication.
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 24 Nov 2011.