Amiodarone Hydrochloride 200 MG: 200 mg daily for 4 weeks
Study summary
The START-POAF pilot study is a prospective, open-label two-arm, randomized controlled trial with blinded assessment of outcomes (PROBE). This pilot study will assess Atrial Fibrillation (AF) recurrence and burden in patients with new-onset AF following cardiac surgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
3 patients per center per month — 2 years Ability to recruit an average of 3 participants per center per month
Less than 10% cross-over rate — 28 days Less than 10% cross-over rate
Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy — 28 days Greater than and equal to 90% of the intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
90% follow-up at 30 days — At 30 days post randomization date Greater than and equal to 90% follow-up at 30 days
Recurrence of atrial fibrillation — In the 28 days measured by continuous ECG monitor placed on day after the participant finishes their 3-5g of loading dose AF recurrence lasting \>= 30 seconds within 28 days
Trial sites (2)
Facility
City
Region
Status
Hamilton General Hospital
Hamilton
Ontario
Recruiting
St. Michael's Hospital
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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