Short-term treatment with amiodarone for new atrial fibrillation after heart surgery
Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial
This study is testing whether a short-term treatment with amiodarone can help people who develop new atrial fibrillation after heart surgery feel better and keep their heart rhythm stable.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Population Health Research Institute Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05841056 on ClinicalTrials.gov |
What this trial studies
The START-POAF pilot study is a randomized controlled trial designed to evaluate the effectiveness of different durations of amiodarone treatment in patients experiencing new-onset atrial fibrillation (AF) following cardiac surgery. Participants will be assigned to receive either an in-hospital loading dose of amiodarone only or the loading dose followed by an additional four weeks of treatment. Throughout the study, patients will wear an electrocardiogram (ECG) monitor to track AF recurrence and burden. The goal is to determine the shortest effective treatment duration that minimizes side effects while maintaining heart rhythm stability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone specific cardiac surgeries within the last 14 days and have experienced new-onset atrial fibrillation.
Not a fit: Patients with a documented history of atrial fibrillation prior to surgery or those with contraindications to amiodarone will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to optimized treatment protocols for managing atrial fibrillation in post-operative cardiac surgery patients, reducing side effects and improving recovery.
How similar studies have performed: Other studies have shown varying success with amiodarone in managing atrial fibrillation, but this specific approach of short-term treatment duration is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged ≥18 years; 2. Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, or combinations thereof within 14 days of randomization; 3. Had new-onset POAF (or flutter), documented by 12-lead ECG or lasting ≥ 1 hour on telemetry. Patients can be in AF or sinus rhythm at the time of randomization; 4. Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery. 5. Expected to be ready for hospital discharge within 48 h of randomization. Exclusion Criteria: 1. Documented preoperative history of paroxysmal, persistent or permanent AF; 2. Planned use of a class I or III anti-arrhythmic drug (other than study drug); 3. Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter); 4. Known allergy to ECG adhesives; 5. Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR \> 240 ms, high-grade AV block). 6. Individuals who are pregnant, breastfeeding, or of childbearing potential - female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening
Where this trial is running
Hamilton, Ontario
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: William McIntyre, MD — Population Health Research Institute
- Study coordinator: Ingrid Copland
- Email: start-poaf@phri.ca
- Phone: 905-512-4940
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.