Amiodarone to Prevent Post-Operative Arrhythmias

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Collaborators: Heart and Stroke Foundation of Canada; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Amiodarone

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