Clinical trial NCT00251706: Amiodarone to Prevent Post-Operative Arrhythmias
Official title: Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
atrial flutter
amiodarone
post-operative
coronary artery bypass surgery
valve replacement or repair
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-11-10
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: more than 5 minutes of post-operative atrial tachyarrhythmia
measure: ventricular response rate of atrial tachyarrhythmias
measure: burden of post-operate atrial tachyarrhythmias
measure: length of hospital stay
Secondary outcomes:
measure: withdrawal of full-dose blinded therapy
measure: non-fatal post-operative complications
measure: hospital mortality
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Libin Cardiovascular Institute / University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: L. Brent Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1001/jama.294.24.3093.