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

Phase 4

Not yet recruiting

• Conditions: Atrial Fibrillation; Surgery, Cardiac
• Interventions: Drug: Amiodarone

• Registration Number: NCT05543278
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-16
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Study Start: 2024-02-01
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amiodarone Arm	Amiodarone	In addition to the regular care provided to cardiac surgery patients, those in the Amiodarone Arm will also receive the amiodarone regimen.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Stroke	Either in-hospital or within 30 days of procedure	characterized by deficits lasting \> 24 hours and/or imaging findings of infarction
Postoperative hospital length of stay	Up to 90 days	The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge.
Readmission	Within 30 days of procedure	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.
Operative mortality	Either in-hospital or within 30 days of procedure	Operative mortality as defined by either in-hospital death or death within 30 days of discharge.
Myocardial infarction	Either in-hospital or within 30 days of procedure	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.
Persistence of atrial fibrillation at discharge	Up to 90 days	Atrial fibrillation as diagnosed by final ECG
Transient ischemic attack	Either in-hospital or within 30 days of procedure	characterized by examination findings lasting \< 24 hours without associated imaging findings
Electrical cardioversion	Either in-hospital or within 30 days of procedure	Whether the patient required electrical cardioversion for hemodynamically unstable atrial fibrillation
Hemodynamic instability	Either in-hospital or within 30 days of procedure	New hemodynamic instability (mean arterial pressure \< 65 mmHg) after surgery
Initiation of systemic anticoagulation	Either in-hospital or within 30 days of procedure	New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation
Symptomatic bradycardia	Either in-hospital or within 30 days of procedure	Symptomatic bradycardia (HR \< 55 bpm) requiring intervention
Number of patients with Amiodarone-related pulmonary toxicity	Either in-hospital or within 30 days of procedure	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.