Amiodarone to Prevent Post-Operative Arrhythmias

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2004-09-30

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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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amiodarone

Intervention Type DRUG

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

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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L. Brent Mitchell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Libin Cardiovascular Institute / University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT

PMID: 16380589 (View on PubMed)

Other Identifiers

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CIHR MCT-14764

Identifier Type: -

Identifier Source: secondary_id

PAPABEAR