Oral Amiodarone for Atrial Fibrillation
(AAA Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken more than 10 g of amiodarone in the past 6 months or other similar heart medications in the past 3 months.
What data supports the effectiveness of the drug Amiodarone for treating atrial fibrillation?
Research shows that oral amiodarone is effective in controlling heart rate in patients with persistent atrial fibrillation, and it is also effective in converting recent atrial fibrillation to normal rhythm. Additionally, long-term use of amiodarone has been found to be safe and effective in maintaining sinus rhythm in patients with persistent atrial fibrillation.12345
Is oral amiodarone generally safe for humans?
How does the drug amiodarone differ from other treatments for atrial fibrillation?
Amiodarone is unique because it can be taken orally and is effective for controlling heart rate in patients with persistent atrial fibrillation, especially after digitalisation (a process to stabilize heart rhythm). Unlike some other treatments, it is a potent antiarrhythmic drug that can be used both for rate control during exercise and daily activities.1451011
Research Team
Satish R Raj, MD MSCI
Principal Investigator
University of Calgary
Eligibility Criteria
This trial is for adults with recent atrial fibrillation or flutter, confirmed by ECG, who have symptoms and are on blood thinners like warfarin or direct oral anticoagulants. It's not for those who've had a lot of amiodarone recently, bad reactions to cardioversion, severe heart issues, very low thyroid without treatment, serious kidney/liver disease, certain heart rhythm problems without a pacemaker, extremely low blood pressure or pregnant/breastfeeding women.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of 2000 mg amiodarone or placebo, followed by cardiac monitoring for 48 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse event monitoring and ECG confirmation of heart rhythm
Treatment Details
Interventions
- Amiodarone Hydrochloride
- Placebo
Amiodarone Hydrochloride is already approved in United States, European Union, Canada for the following indications:
- Ventricular arrhythmias
- Atrial fibrillation
- Ventricular tachycardia
- Ventricular fibrillation
- Atrial fibrillation
- Ventricular arrhythmias
- Atrial fibrillation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor