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

Mass General Brigham

Status and phase: Not yet enrolling; Phase 4

Conditions: Atrial Fibrillation; Surgery, Cardiac

Treatments: Drug: Amiodarone

Study type: Interventional

Funder types: Other

Identifiers

NCT05543278

2022P001732

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

Amiodarone Arm

Experimental group

Description:

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

Treatment:

Drug: Amiodarone

Standard of Care Arm

No Intervention group

Description:

Patients randomized to the Standard of Care Arm will receive the regular care provided to cardiac surgery patients.