Oral Amiodarone for Acute Cardioversion of Atrial Fibrillation Study

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will seek to determine the safety and efficacy of high-dose amiodarone (2000mg), given as a single uniform oral dose, for the treatment of acute atrial fibrillation in both a hospital inpatient and ambulatory outpatient setting. The investigators will conduct a placebo-controlled randomized trial, with outcome ascertainment at 48h.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Amiodarone

Criteria

Inclusion Criteria:

• Acute persistent or paroxysmal atrial fibrillation or atrial flutter with duration < 14 days (continuous with no spontaneous conversions), confirmed by ECG or cardiac telemetry

• History of symptoms associated with atrial fibrillation

• Appropriate anticoagulation (warfarin with an international normalized ratio (INR) > 2.0 or direct oral anticoagulant)

Exclusion Criteria:

• Received > 10 g of amiodarone in the prior 6 months, or other Class III anti-arrhythmic agents in the prior 3 months

• previous severe adverse event following a cardioversion for atrial fibrillation

• Hypothyroid and not on thyroid replacement therapy

• Recent myocardial infarction (within 2 weeks)

• Acute pulmonary oedema requiring hospital admission or New York Heart Association (NYHA) class IV heart failure

• Severe left ventricular dysfunction or left ventricular ejection fraction < 36%, as determined by cardiac imaging

• Sick sinus syndrome, high grade atrioventricular block, ventricular rate < 50 beats per minute in the absence of a mechanical pacemaker

• Severe renal or hepatic disease

• Known congenital long QT syndrome

• Hypotension with systolic blood pressure < 90 mmHg

• Pregnant or breast-feeding women