Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.

Official Title
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Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Conditions
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Surgery, Cardiac, Atrial Fibrillation

Intervention / Treatment
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* Drug: Amiodarone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 18 years of age All genders All non-coronary artery bypass cardiac surgery patients Preoperative normal sinus rhythm Exclusion Criteria: Pre-existing atrial fibrillation or atrial arrhythmias Pre-existing heart block Cardiogenic shock Sick sinus syndrome Marked sinus bradycardia Preoperative amiodarone use Contraindication to amiodarone use PR interval > 240 ms QTc > 550 ms 2nd or 3rd degree heart block Liver impairment (INR > 1.7, AST/ALT > 2x normal) Uncontrolled hyperthyroidism or hypothyroidism Interstitial lung disease Pregnancy and/or breastfeeding Known hypersensitivity to any components of amiodarone, including iodine Emergent operation Planned MAZE or Pulmonary Vein Isolation procedure

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amiodarone Arm<br>In addition to the regular care provided to cardiac surgery patients, those in the Amiodarone Arm will also receive the amiodarone regimen. | Drug: Amiodarone<br>* Patients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.<br>|
| No Intervention: Standard of Care Arm<br>Patients randomized to the Standard of Care Arm will receive the regular care provided to cardiac surgery patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative atrial fibrillation | The occurrence of postoperative atrial fibrillation detected by continuous telemetry, 12-lead electrocardiogram, and/or continuous ambulatory monitoring device through postoperative day 7. | At least 1 minute duration, occurring before or on postoperative day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative mortality | Operative mortality as defined by either in-hospital death or death within 30 days of discharge. | Either in-hospital or within 30 days of procedure | 
| Stroke | characterized by deficits lasting > 24 hours and/or imaging findings of infarction | Either in-hospital or within 30 days of procedure | 
| Transient ischemic attack | characterized by examination findings lasting < 24 hours without associated imaging findings | Either in-hospital or within 30 days of procedure | 
| Electrical cardioversion | Whether the patient required electrical cardioversion for hemodynamically unstable atrial fibrillation | Either in-hospital or within 30 days of procedure | 
| Hemodynamic instability | New hemodynamic instability (mean arterial pressure < 65 mmHg) after surgery | Either in-hospital or within 30 days of procedure | 
| Initiation of systemic anticoagulation | New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation | Either in-hospital or within 30 days of procedure | 
| Myocardial infarction | Myocardial infarction diagnosed based on ECG and laboratory testing including pursued intervention and/or findings from subsequent angiography will be compared between intervention groups. To be considered a myocardial infarction, the diagnosis will have to be confirmed and documented in the chart by a board-certified cardiologist. | Either in-hospital or within 30 days of procedure | 
| Persistence of atrial fibrillation at discharge | Atrial fibrillation as diagnosed by final ECG | Up to 90 days | 
| Postoperative hospital length of stay | The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge. | Up to 90 days | 
| Readmission | Rates of hospital readmission will be estimated for patients in each of the study intervention groups. Readmissions will be counted in this calculation if patients are admitted to the hospital. Emergency room visits without admission and outpatient visits will not count toward this calculation of readmission rates. | Within 30 days of procedure | 
| Symptomatic bradycardia | Symptomatic bradycardia (HR < 55 bpm) requiring intervention | Either in-hospital or within 30 days of procedure | 
| Number of patients with Amiodarone-related pulmonary toxicity | Clinical diagnosis of amiodarone-related pulmonary toxicity that uses a combination of x-ray findings consistent with known amiodarone-related pulmonary toxicity and clinical findings including shortness of breath, non-productive cough, and other diagnoses have been excluded. | Either in-hospital or within 30 days of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative atrial fibrillation, POAF