Clinical trial NCT02132767
Conditions: Postoperative Atrial Fibrillation
Keywords: Heart surgery Cardiac surgery Coronary artery bypass Mitral valve surgery Aortic valve surgery Atrial fibrillation Atrial flutter Cardiac arrhythmia Valve surgery
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2014-05-01; Completion date: 2015-09-01
Enrollment: 523 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.

Detailed description:
The purpose of the research is to compare two strategies for treating atrial fibrillation or atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is the most common complication after cardiac surgery. AF is when the upper chambers of the heart (atria) experience disorganized electrical activity which causes the heart beat to be irregular. The two treatment strategies to be used in this study are called rhythm control and rate control. The rhythm control strategy will attempt to bring the heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. The rate control strategy will attempt to bring the heart rate to less than 100 beats per minute at rest using medications known and recommended to control heart rate. Both strategies are commonly used to treat AF. All of the medications that will be used in this study are the standard of care for use in patients experiencing AF. This research seeks to determine whether rhythm control is better than rate control in patients with AF after cardiac surgery.

Arms: arm 1: Rhythm Control in post-operative AF

Amiodarone and/or DC-cardioversion

Amiodarone Initial Dose

* Oral: 400 mg po TID for 3 days is recommended
* For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose
* Oral: at least 200 mg/day to be continued until 60 days after randomization
* If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started

DC-Cardioversion - frequency and duration determined by medical professional as medically needed arm 2: Rate Control in post-operative AF

Beta-blocker and/or Calcium channel blockers and/or Digoxin

Dose, frequency and duration determined by medical professional as medically needed
Interventions: intervention 1: Amiodarone intervention 2: DC-cardioversion intervention 3: Rate Control
Intervention descriptions: intervention 1: Amiodarone Initial Dose

* Oral: 400 mg po TID for 3 days is recommended
* For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose
* Oral: at least 200 mg/day to be continued until 60 days after randomization
* If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started intervention 2: DC-Cardioversion - frequency and duration determined by medical professional as medically needed intervention 3: Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed

Protocol documents: