Amiodarone to Prevent Post-Operative Arrhythmias

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: amiodarone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amiodarone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| withdrawal of full-dose blinded therapy |  |  | 
| non-fatal post-operative complications |  |  | 
| hospital mortality |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, atrial flutter, amiodarone, post-operative, coronary artery bypass surgery, valve replacement or repair