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

Sponsor
Massachusetts General Hospital
Study ID
NCT05543278
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amiodarone — DRUG
    Patients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.

Study Details

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.

Key Dates

First listed
Sep 16, 2022
Start date
Jan 31, 2027
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Amiodarone Arm
    In addition to the regular care provided to cardiac surgery patients, those in the Amiodarone Arm will also receive the amiodarone regimen.
  • No Intervention: Standard of Care Arm
    Patients randomized to the Standard of Care Arm will receive the regular care provided to cardiac surgery patients.

Primary Outcome Measure

Postoperative atrial fibrillation [ Time Frame: At least 1 minute duration, occurring before or on postoperative day 7 ]

Central Contacts

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