Atrial FibrillationPhase 4NCT00127712
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
A Phase 4 study testing Amiodarone in people with Atrial Fibrillation, run by Indiana University at 1 site in United States.
Trial summary
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are to: Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac open-chest surgery; Determine the influence of… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Amiodarone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Feb 2008
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females over the age of 40
- Scheduled to undergo pneumonectomy or lobectomy
Who cannot join
- History (hx) of atrial fibrillation
- Prior severe side effects from amiodarone
- Elevated liver enzymes >3 times the upper limit of normal (UNL)
- QTc interval > 450 ms
- Receiving class Ia or class III antiarrhythmics
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are to:
- Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac open-chest surgery;
- Determine the influence of the prevention of AF following non-cardiac thoracic surgery on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical duration of stay in a hospital unit that employs cardiac monitoring; and duration of post-surgical hospital stay; and
- Determine the safety of amiodarone for the prevention of AF following non-cardiac open-chest surgery.
Read the detailed description
Thousands of patients undergo major non-cardiac open-chest surgery in the United States each year. These surgeries most often consist of lung surgery, in which one lobe of the lung is removed (lobectomy) or the entire lung is removed (pneumonectomy).
A major complication of these non-cardiac open-chest surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing these procedures. AF is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). The average time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following major non-cardiac open-chest surgery can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. Further, the risk of death following non-cardiac open-chest surgery is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following non-cardiac open-chest surgery is associated with severe, potentially life-threatening consequences. Prevention of this irregular heartbeat in these patients may therefore be very important.
Amiodarone is a medication that is known to be effective for prevention and treatment of AF that occurs in patients who have not undergone surgery. In addition, amiodarone has been shown to be effective for prevention of AF following open-chest heart surgery. However, the use of medications for prevention of AF following non-cardiac open-chest surgery has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in patients undergoing these procedures. In addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.
- Conditions
- Atrial Fibrillation
- Being tested
- Amiodarone
- Keywords
- amiodarone, atrial fibrillation, surgical procedures, thoracic
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone | Experimental | Amiodarone 1050 mg via continuous intravenous infusion for 24 hours followed by 400 mg orally twice daily for 6 days Receives: Drug: Amiodarone |
| No treatment | No intervention | Patients in this group receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Atrial Fibrillation Requiring Treatment
Measured: 7 days
Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds
Measured: 7 days
Secondary outcomes (2)
Length of Intensive Care Unit Stay
Measured: Duration of hospitalization
Length of Hospital Stay
Measured: Duration of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University
- Responsible party
- Principal investigator, James E. Tisdale, Purdue University
- Investigators
- James E Tisdale, PharmD, Principal investigator, Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127712
- Sponsor's protocol ID
- 0407-16
- Status last verified
- Sep 2013
- First submitted
- 4 Aug 2005
- Last updated
- 18 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tisdale JE, Wroblewski HA, Wall DS, Rieger KM, Hammoud ZT, Young JV, Kesler KA. A randomized trial evaluating amiodarone for prevention of atrial fibrillation after pulmonary resection. Ann Thorac Surg. 2009 Sep;88(3):886-93; discussion 894-5. doi: 10.1016/j.athoracsur.2009.04.074.
PubMed 19699916
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
- ClinicalTrials.gov ID
- NCT00127712
- Acronym / sponsor ID
- 0407-16
- Conditions
- Atrial Fibrillation
- Keywords
- amiodarone, atrial fibrillation, surgical procedures, thoracic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University
- Study start
- Sep 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 8 Aug 2005 (estimated)
- Results
- Posted 24 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are to:
- Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac open-chest surgery;
- Determine the influence of the prevention of AF following non-cardiac thoracic surgery on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical duration of stay in a hospital unit that employs cardiac monitoring; and duration of post-surgical hospital stay; and
- Determine the safety of amiodarone for the prevention of AF following non-cardiac open-chest surgery.
Detailed description
Thousands of patients undergo major non-cardiac open-chest surgery in the United States each year. These surgeries most often consist of lung surgery, in which one lobe of the lung is removed (lobectomy) or the entire lung is removed (pneumonectomy).
A major complication of these non-cardiac open-chest surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing these procedures. AF is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). The average time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following major non-cardiac open-chest surgery can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. Further, the risk of death following non-cardiac open-chest surgery is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following non-cardiac open-chest surgery is associated with severe, potentially life-threatening consequences. Prevention of this irregular heartbeat in these patients may therefore be very important.
Amiodarone is a medication that is known to be effective for prevention and treatment of AF that occurs in patients who have not undergone surgery. In addition, amiodarone has been shown to be effective for prevention of AF following open-chest heart surgery. However, the use of medications for prevention of AF following non-cardiac open-chest surgery has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in patients undergoing these procedures. In addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone | Experimental | Drug: AmiodaroneAmiodarone 1050 mg via continuous intravenous infusion for 24 hours followed by 400 mg orally twice daily for 6 days |
| No treatment | No intervention | –Patients in this group receive no intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or females over the age of 40
- Scheduled to undergo pneumonectomy or lobectomy
Key exclusion criteria (5 listed)
- History (hx) of atrial fibrillation
- Prior severe side effects from amiodarone
- Elevated liver enzymes >3 times the upper limit of normal (UNL)
- QTc interval > 450 ms
- Receiving class Ia or class III antiarrhythmics
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 |
|---|---|---|
| Amiodarone | Drug | Amiodarone |
Primary outcome
Incidence of Atrial Fibrillation Requiring Treatment
Time frame: 7 days
Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds
Time frame: 7 days
2 secondary outcomes
Length of Intensive Care Unit Stay
Time frame: Duration of hospitalization
Length of Hospital Stay
Time frame: Duration of hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19699916Tisdale JE, Wroblewski HA, Wall DS, Rieger KM, Hammoud ZT, Young JV, Kesler KA. A randomized trial evaluating amiodarone for prevention of atrial fibrillation after pulmonary resection. Ann Thorac Surg. 2009 Sep;88(3):886-93; discussion 894-5. doi: 10.1016/j.athoracsur.2009.04.074.
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Atrial Fibrillation (AF)
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.
James E Tisdale, PharmD principal investigator
Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University
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 Amiodarone in people with Atrial Fibrillation, run by Indiana University at 1 site in United States.
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 5 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 18 Sep 2013. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2010). 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?
Incidence of Atrial Fibrillation Requiring Treatment (time frame: 7 days). 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?
On the ClinicalTrials.gov record for NCT00127712, 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 18 Sep 2013.