42 Participants Needed

Oral Amiodarone for Atrial Fibrillation

(AAA Trial)

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SR
RH
Overseen ByRasha Hamzeh, RN
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Calgary
Must be taking: Anticoagulants
Prior Safety DataThis treatment has passed at least one previous human 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?

Amiodarone, used for heart rhythm problems, can have serious side effects, including low blood pressure and other toxic effects. It's important for patients to be monitored closely by healthcare providers while taking it.46789

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

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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

I am on blood thinners with specific monitoring levels.
I have experienced symptoms related to an irregular heartbeat.
I have had atrial fibrillation or flutter for less than 14 days, confirmed by a heart monitor.

Exclusion Criteria

I have severe heart failure or have been hospitalized for sudden lung swelling.
I have not taken more than 10g of amiodarone or any Class III anti-arrhythmic drugs recently.
I have an underactive thyroid and am not taking medication for it.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of 2000 mg amiodarone or placebo, followed by cardiac monitoring for 48 hours

48 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event monitoring and ECG confirmation of heart rhythm

1 week
1 follow-up call

Treatment Details

Interventions

  • Amiodarone Hydrochloride
  • Placebo
Trial OverviewThe study tests if a high dose (2000mg) of Amiodarone given orally can safely and effectively treat acute atrial fibrillation in both hospital and outpatient settings compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo and followed up after 48 hours.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral AmiodaroneExperimental Treatment1 Intervention
Amiodarone hydrochloride 2000 mg
Group II: PlaceboPlacebo Group1 Intervention
Oral placebo

Amiodarone Hydrochloride is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Cordarone for:
  • Ventricular arrhythmias
  • Atrial fibrillation
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Approved in European Union as Cordarone for:
  • Ventricular tachycardia
  • Ventricular fibrillation
  • Atrial fibrillation
🇨🇦
Approved in Canada as Pacerone for:
  • Ventricular arrhythmias
  • Atrial fibrillation

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Findings from Research

In a study of 53 patients with chronic atrial fibrillation, oral amiodarone significantly reduced heart rates during exercise and daily activities compared to placebo, indicating its efficacy for rate control.
Amiodarone, when used alongside digoxin, is a viable alternative for heart rate management in patients with atrial fibrillation, especially when traditional treatments like calcium channel blockers or beta-blockers are not suitable.
Efficacy and safety of oral amiodarone in controlling heart rate in patients with persistent atrial fibrillation who have undergone digitalisation.Kochiadakis, GE., Kanoupakis, EM., Igoumenidis, NE., et al.[2018]
In a study of 160 patients with recent atrial fibrillation, oral doses of flecainide, amiodarone, and propafenone were all significantly more effective than placebo in converting patients to sinus rhythm within 24 hours, with conversion rates of 87.5%, 85%, and 85% respectively compared to only 17.5% for placebo.
Flecainide and propafenone showed quicker conversion rates within 3 hours (57.5% and 45% respectively), while amiodarone was more effective between 6 and 24 hours, indicating that different antiarrhythmic drugs may have varying onset times for effectiveness.
Pharmacological conversion of recent atrial fibrillation: a randomized, placebo-controlled study of three antiarrhythmic drugs.Balla, I., Petrela, E., Kondili, A.[2013]
Amiodarone is effective in achieving sinus rhythm in patients with persistent atrial fibrillation, showing a significant improvement compared to placebo or rate control drugs (21.3 vs 9.2 per 100 patient-years).
The use of amiodarone does not increase long-term mortality risk, but it is associated with a higher rate of treatment discontinuation due to adverse effects (10.7 vs 1.9 per 100 patient-years).
Benefits and risks of long-term amiodarone therapy for persistent atrial fibrillation: a meta-analysis.Doyle, JF., Ho, KM.[2023]

References

Efficacy and safety of oral amiodarone in controlling heart rate in patients with persistent atrial fibrillation who have undergone digitalisation. [2018]
Pharmacological conversion of recent atrial fibrillation: a randomized, placebo-controlled study of three antiarrhythmic drugs. [2013]
Benefits and risks of long-term amiodarone therapy for persistent atrial fibrillation: a meta-analysis. [2023]
Chronic and acute effects of dronedarone on the action potential of rabbit atrial muscle preparations: comparison with amiodarone. [2019]
Intravenous and oral administration of amiodarone for the treatment of recent onset atrial fibrillation after digoxin administration. [2013]
Amiodarone (Nexterone) injection for the treatment and prophylaxis of frequently recurring ventricular fibrillation. [2013]
Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. [2023]
Safety update: monitoring patients taking amiodarone. [2022]
Clinical use and pharmacology of amiodarone. [2019]
Dronedarone. [2021]
Emerging pharmacotherapies for the treatment of atrial fibrillation. [2018]