Short-term treatment with amiodarone for new atrial fibrillation after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥18 years;
2. Have undergone cardiac surgery including CABG, valve surgery, surgery on the aorta, 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 (Total Lung Capacity (TLC) \<50% predicted) or obstructive (Forced Expiry Volume (FEV1) \<49% predicted) 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 it's running

• Hamilton General Hospital
  Hamilton, Ontario, Canada Recruiting
• St. Michael's Hospital
  Toronto, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.