Rapid heart rhythms originating from the upper heart chambers (atrial tachyarrhythmias) are very common after open-heart surgery. The hypothesis of the PAPABEAR study is that a brief (13 day) peri-operative course of oral amiodarone therapy would be effective and safe for the prevention of these post-operative atrial tachyarrhythmias...
Date First Received: November 8, 2005
Last Updated: May 4, 2006
Verified by: University of Calgary, November 2005
Clinical Trial Phase: Phase 3 | Start Date: February 1999
Overall Status: Completed
Estimated Enrollment: 600
Brief Summary
Official Title: “Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR”
Condition Keyword(s):
Intervention(s):
Rapid heart rhythms originating from the upper heart chambers (atrial tachyarrhythmias) are very common after open-heart surgery. The hypothesis of the PAPABEAR study is that a brief (13 day) peri-operative course of oral amiodarone therapy would be effective and safe for the prevention of these post-operative atrial tachyarrhythmias.
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
Six hundred and one patients who were about to undergo non-emergent open-heart surgery were randomized to receive oral amiodarone (10 mg/kg/day) or its matching placebo from six days before surgery through 6 days after surgery. The major outcome tracked was the incidence of more than 5 minutes of an atrial tachyarrhythmia that prompted therapy by the sixth post-operative day. Safety was assessed by the incidence of dosage reduction of blinded therapy, non-fatal post-operative complications, and in-hospital mortality. The randomization scheme was stratified to permit separate analysis of patients less than versus more than or equal to 65 years of age, patients having coronary artery bypass surgery alone versus those having valve surgery with or without concomitant bypass surgery, and patients also receiving versus not also receiving concomitant therapy with a beta-blocker medication.
Intervention(s) in this Clinical Trial
- Drug: amiodarone
Outcome Measures for this Clinical Trial
Primary Measures
- more than 5 minutes of post-operative atrial tachyarrhythmia
- ventricular response rate of atrial tachyarrhythmias
- burden of post-operate atrial tachyarrhythmias
- length of hospital stay
Secondary Measures
- withdrawal of full-dose blinded therapy
- non-fatal post-operative complications
- hospital mortality
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- non-emergent coronary artery bypass surgery or valve replacement or repair
- informed consent
Exclusion Criteria:
- any heart rhythm other than sinus
- myocardial infarction within two weeks
- Class IV congestive Heart Failure
- requirement for antiarrhythmic drug therapy
- history of sustained atrial tachyarrhythmias
- treatment with amiodarone within 3 months
- sinus bradycardia (less than 50 bpm) while awake
- advanced conduction system disease
- prolonged QT interval
- clinical hypo- or hyperthyroidism
- women of child bearing potential
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Calgary
Overall Clinical Trial Officials and Contacts
L. Brent Mitchell, MD Principal Investigator University of Calgary
Related Publications
Citations Reporting Results
Mitchell LB, Exner DV, Wyse DG, Connolly CJ, Prystai GD, Bayes AJ, Kidd WT, Kieser T, Burgess JJ, Ferland A, MacAdams CL, Maitland A. Prophylactic Oral Amiodarone for the Prevention of Arrhythmias that Begin Early After Revascularization, Valve Replacement, or Repair: PAPABEAR: a randomized controlled trial. JAMA. 2005 Dec 28;294(24):3093-100.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00251706
Study ID Number: PAPABEAR
ClinicalTrials.gov Identifier: NCT00251706
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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