Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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Atrial fibrillation (AF) is the most common abnormal heart rhythm in the world. In patients who have cardiac surgery, new AF is found as an early complication in more than one out of every four surgeries. In the weeks and months after heart surgery, patients who have new AF take a medication called amiodarone to keep their heart in rhythm as it heals. If the heart goes back into AF, patients can have symptoms of heart racing, heart failure (fluid on the lungs) or stroke. Although amiodarone is effective, it can have side effects like dizziness, nausea and slow heart rate. It may also damage the lungs, liver and thyroid gland. Many patients are not able to complete their full prescribed course after surgery. Therefore, it is crucial that the investigators find the shortest possible length of treatment with amiodarone that will keep the heart in rhythm while minimizing the chance of side effects or organ damage. The START-POAF Pilot Randomized Trial will compare two different durations of amiodarone treatment: 1) in-hospital load only and 2) in-hospital load plus 4 weeks after loading dose. All participants will wear an electrocardiogram (ECG) monitor for 4 weeks the day after they complete their loading dose. The investigators will compare the amount of AF seen on the ECG between the two groups.

Official Title
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Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial

Conditions
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Atrial Fibrillation New Onset

Intervention / Treatment
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* Drug: Amiodarone Hydrochloride 200 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years; Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, or combinations thereof within 14 days of randomization; 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; Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery. Expected to be ready for hospital discharge within 48 h of randomization. Exclusion Criteria: Documented preoperative history of paroxysmal, persistent or permanent AF; Planned use of a class I or III anti-arrhythmic drug (other than study drug); Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter); Known allergy to ECG adhesives; Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR > 240 ms, high-grade AV block). 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 ratio to receive amiodarone 200 mg maintenance therapy daily for four weeks or no maintenance therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amiodarone maintenance therapy<br>Amiodarone 200 mg daily for four weeks | Drug: Amiodarone Hydrochloride 200 MG<br>* 200 mg daily for 4 weeks<br>* Other names: Cordarone;|
| No Intervention: No Amiodarone maintenance therapy<br>No ongoing Amiodarone maintenance therapy for four weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 patients per center per month | Ability to recruit an average of 3 participants per center per month | 2 years | 
| Less than 10% cross-over rate | Less than 10% cross-over rate | 28 days | 
| Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy | Greater than and equal to 90% of the intervention group taking at least 80% of their amiodarone 4 week maintenance therapy | 28 days | 
| 90% follow-up at 30 days | Greater than and equal to 90% follow-up at 30 days | At 30 days post randomization date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burden of atrial fibrillation | Defined as percent time in atrial fibrillation | In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose | 
| Time to first AF > 6 minutes, >6 hours and >24 hours | Time to first AF > 6 minutes, >6 hours and >24 hours reported from the continuous ECG monitor | In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose | 
| Participants with at least one episode >6 minutes, >6 hours and >24 hours | Proportion of participants with at least one episode > 6 minutes, >6 hours and >24 hours reported from the continuous ECG | In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, heart rhythm monitoring, amiodarone