Atrial FibrillationPhase 3NCT00300495
Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection
A Phase 3 study testing Amiodarone in people with Atrial Fibrillation and Lung Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Lung Cancer
- What is being tested?
- Amiodarone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to 13 Oct 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable lung nodule or mass
Who cannot join
- Allergy to amiodarone
- Currently taking amiodarone
- Documented atrial fibrillation within past 12 months
- Known pulmonary fibrosis
- Known hepatic dysfunction
- Thyroid disease
Show all 10Show fewer
- 2nd or 3rd degree heart block
- Severe SA node disease
- Bradycardia-induced syncope
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
Read the detailed description
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.
We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
- Conditions
- Atrial Fibrillation, Lung Cancer
- Being tested
- Amiodarone, Control arm, standard care
- Keywords
- Atrial fibrillation, Lung cancer, Pulmonary resection, Post-operative complications
- Medical subject headings
- Atrial Fibrillation, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
Also called Cordarone, Pacerone
Perioperative orally administered
Control arm, standard careOther
Control
| Study group | Role | What they receive |
|---|---|---|
| 1 - Amiodarone | Experimental | Perioperative amiodarone Receives: Drug: Amiodarone |
| 2 - Control | Active comparator | Control arm, standard care with no perioperative amiodarone Receives: Other: Control arm, standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-operative Atrial Fibrillation
Number of patients with post-operative atrial fibrillation
Measured: 30 days
Secondary outcomes (1)
Length of Post-operative Hospital Stay
Length of hospital stay after the operation
Measured: 1 week on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completion13 Oct 2009
- Study completion13 Oct 2009
Why it stopped: Unable to accrual total number of participants during study period.
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malcolm DeCamp, Beth Israel Deaconess Medical Center
- Investigators
- Malcolm M DeCamp, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300495
- Sponsor's protocol ID
- 2005P000376
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2006
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection
- ClinicalTrials.gov ID
- NCT00300495
- Acronym / sponsor ID
- 2005P000376
- Conditions
- Atrial Fibrillation, Lung Cancer
- Keywords
- Atrial fibrillation, Lung cancer, Pulmonary resection, Post-operative complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to accrual total number of participants during study period.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Feb 2006 (actual)
- Primary completion
- 13 Oct 2009 (actual)
- Study completion
- 13 Oct 2009 (actual)
- First posted
- 9 Mar 2006 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
Detailed description
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.
We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Amiodarone | Experimental | Drug: AmiodaronePerioperative amiodarone |
| 2 - Control | Active comparator | Other: Control arm, standard careControl arm, standard care with no perioperative amiodarone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resectable lung nodule or mass
Key exclusion criteria (10 listed)
- Allergy to amiodarone
- Currently taking amiodarone
- Documented atrial fibrillation within past 12 months
- Known pulmonary fibrosis
- Known hepatic dysfunction
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 |
|---|---|---|
| AmiodaroneAlso: Cordarone, PaceronePerioperative orally administered | Drug | 1 - Amiodarone |
| Control arm, standard careControl | Other | 2 - Control |
Primary outcome
Incidence of Post-operative Atrial Fibrillation
Time frame: 30 days
Number of patients with post-operative atrial fibrillation
1 secondary outcome
Length of Post-operative Hospital Stay
Time frame: 1 week on average
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Malcolm M DeCamp, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone in people with Atrial Fibrillation and Lung Cancer, run by Beth Israel Deaconess Medical Center 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 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: stopped early, as of the sponsor's last update on 28 Apr 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 28 Apr 2017). 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 Post-operative Atrial Fibrillation (time frame: 30 days). 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 28 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.