NCT05543278

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery, Cardiac
• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Amiodarone	Patients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-12-01
• First posted: 2022-09-16
• Last updated: 2026-03-16

Regulatory

• FDA-regulated drug study