Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>= 18 years of age
All genders
All non-coronary artery bypass cardiac surgery patients
Preoperative normal sinus rhythm
Disqualifiers
Pre-existing atrial fibrillation or atrial arrhythmias
Pre-existing heart block
Cardiogenic shock
Sick sinus syndrome
Trial design
Design model
Parallel
Treatments tested in this trial
Amiodarone
DrugPatients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.
Treatment groups
242 Participants
are divided into 2 treatment groupsGroup A: Amiodarone ArmExperimental treatment 1 intervention
Group B: Standard of Care ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
At least 1 minute duration, occurring before or on postoperative day 7Secondary outcomes
1
Operative mortality
Operative mortality as defined by either in-hospital death or death within 30 days of discharge.
Time frame
Either in-hospital or within 30 days of procedure2
Stroke
characterized by deficits lasting \> 24 hours and/or imaging findings of infarction
Time frame
Either in-hospital or within 30 days of procedure3
Transient ischemic attack
characterized by examination findings lasting \< 24 hours without associated imaging findings
Time frame
Either in-hospital or within 30 days of procedure4
Electrical cardioversion
Whether the patient required electrical cardioversion for hemodynamically unstable atrial fibrillation
Time frame
Either in-hospital or within 30 days of procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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