Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

Study Overview
=================
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.

Official Title
-----------------
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

Conditions
-----------------
Postoperative Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Amiodarone
* Procedure: DC-cardioversion
* Drug: Rate Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Enrollment Inclusion Criteria: Age > 18 years Undergoing heart surgery for coronary artery bypass (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations Hemodynamically stable Randomization Inclusion Criteria AF that persists for > 60 minutes or recurrent (more than one) episodes of AF up to 7 days after surgery during the index hospitalization. Exclusion Criteria: LVAD insertion or heart transplantation Maze procedure TAVR History of or planned mechanical valve replacement Correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or PFO) History of AF or AFL History of AF or AFL ablation Contraindications to warfarin or amiodarone Need for long-term anticoagulation Concurrent participation in an interventional (drug or device) trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rhythm control<br>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 | Drug: Amiodarone<br>* 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<br>* Other names: Cordarone;Procedure: DC-cardioversion<br>* DC-Cardioversion - frequency and duration determined by medical professional as medically needed<br>* Other names: Direct Current Cardioversion;|
| Active Comparator: Rate control<br>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 | Drug: Rate Control<br>* Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed<br>* Other names: Digoxin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Days in Hospital | The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy. | Within 60 days of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Conversion to Sustained, Stable Non-AF Rhythm |  | Up to index hospital discharge or 7 days post surgery, whichever came first | 
| Heart Rhythm Comparison | Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge | Hospital discharge | 
| Heart Rhythm Comparison | Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization | 30 days after randomization | 
| Heart Rhythm Comparison | Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization | 60 days after randomization | 
| Length of Stay (Index Hospitalization) | Overall length of stay for the index hospitalization | Within 60 days post surgery | 
| Length of Stay (Rehospitalization, Including ED Visits) | Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits | Within 60 days of randomization | 
| Outpatient Interventions | Compare frequency of outpatient visits between groups for any cause and AF-related causes | Within 60 days of randomization | 
| AF- or Treatment-related Events |  | Within 60 days of randomization | 
| Cost (Hospital) | Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups | Within 60 days of randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart surgery, Cardiac surgery, Coronary artery bypass, Mitral valve surgery, Aortic valve surgery, Atrial fibrillation, Atrial flutter, Cardiac arrhythmia, Valve surgery