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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiodarone maintenance therapy | Active Comparator | Amiodarone 200 mg daily for four weeks |
|
| No Amiodarone maintenance therapy | No Intervention | No ongoing Amiodarone maintenance therapy for four weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiodarone Hydrochloride 200 MG | Drug | 200 mg daily for 4 weeks |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure | Number of participants who experience heart failure | 90 days after randomization |
| Atrial Fibrillation | Number of participants who experience atrial fibrillation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingrid Copland | Contact | 905-512-4940 | start-poaf@phri.ca |
| Name | Affiliation | Role |
|---|---|---|
| William McIntyre, MD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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1:1 ratio to receive amiodarone 200 mg maintenance therapy daily for four weeks or no maintenance therapy
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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 |
| 90 days after randomization |
| A composite of stroke, myocardial infarction and cardiovascular death | Number of participants who have at least one of the following: stroke, myocardial infarction or cardiovascular death | 90 days after randomization |
| Major bleeding | Number of participants who experience a major bleed | 90 days after randomization |
| Systemic arterial embolism | Number of participants who experience a systemic arterial embolism | 90 days after randomization |
| Atrial Fibrillation Effect on QualiTy of life (AFEQT) Questionnaire | The Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) evaluates symptoms, daily activities, and treatment concerns participants have related to atrial fibrillation and will be completed on all participants | Collected at baseline, 30 day follow-up and 90 day follow-up |
| SF-12 Questionnaire | The SF-12 questionnaire which assesses physical and mental health will be completed on all participants | Collected at baseline, 30 day follow-up and 90 day follow-up |
| Electrical cardioversion | Proportion of participants who undergo electrical cardioversion | Randomization to 90 days |
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1C9 | Canada |
|