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Completed

NCT Number: NCT02132767

Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

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.

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Key information

Conditions

Postoperative Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amiodarone

Drug

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

Other names: Cordarone

DC-cardioversion

Procedure

DC-Cardioversion - frequency and duration determined by medical professional as medically needed

Other names: Direct Current Cardioversion

Rate Control

Drug

Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed

Other names: Beta-blocker, Calcium channel blockers, Digoxin

Primary outcomes

  1. Total Number of Days in Hospital

    Time frame: Within 60 days of randomization

    The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.

Secondary outcomes

  1. Time to Conversion to Sustained, Stable Non-AF Rhythm

    Time frame: Up to index hospital discharge or 7 days post surgery, whichever came first

  2. Heart Rhythm Comparison

    Time frame: Hospital discharge

    Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge

  3. Heart Rhythm Comparison

    Time frame: 30 days after randomization

    Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization

  4. Heart Rhythm Comparison

    Time frame: 60 days after randomization

    Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization

  5. Length of Stay (Index Hospitalization)

    Time frame: Within 60 days post surgery

    Overall length of stay for the index hospitalization

  6. Length of Stay (Rehospitalization, Including ED Visits)

    Time frame: Within 60 days of randomization

    Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits

  7. Outpatient Interventions

    Time frame: Within 60 days of randomization

    Compare frequency of outpatient visits between groups for any cause and AF-related causes

  8. AF- or Treatment-related Events

    Time frame: Within 60 days of randomization

  9. Cost (Hospital)

    Time frame: Within 60 days of randomization

    Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 7, 2014
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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