Using oral amiodarone to treat acute atrial fibrillation
Oral Amiodarone for Acute Cardioversion of Atrial Fibrillation Study
This study is testing if a single high dose of oral amiodarone can safely help people with recent episodes of atrial fibrillation feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT04594746 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of a high-dose oral amiodarone (2000mg) given as a single dose for the treatment of acute atrial fibrillation in both hospital and outpatient settings. It is a placebo-controlled randomized trial, with outcomes assessed 48 hours after administration. The research aims to provide an effective rhythm control strategy for patients experiencing persistent atrial fibrillation, which can lead to significant health complications. The study will include patients with acute persistent or paroxysmal atrial fibrillation or atrial flutter lasting less than 14 days.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with acute persistent or paroxysmal atrial fibrillation or atrial flutter lasting less than 14 days, who have a history of related symptoms and are appropriately anticoagulated.
Not a fit: Patients who have received significant prior doses of amiodarone or other anti-arrhythmic agents, or those with severe heart conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a rapid and effective method for restoring normal heart rhythm in patients with acute atrial fibrillation.
How similar studies have performed: Previous studies have shown that amiodarone can be effective for rhythm control in atrial fibrillation, indicating that this approach has a foundation in existing research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Satish R Raj, MD MSCI — University of Calgary
- Study coordinator: Satish R Raj, MD MSCI
- Email: autonomic.research@ucalgary.ca
- Phone: 4032106152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.