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Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02132767
First Posted: May 7, 2014
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Annetine Gelijns, Icahn School of Medicine at Mount Sinai
  Purpose
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.

Condition Intervention Phase
Postoperative Atrial Fibrillation Drug: Amiodarone Procedure: DC-cardioversion Drug: Rate Control Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Annetine Gelijns, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Time to Conversion to Sustained, Stable Non-AF Rhythm [ Time Frame: Up to index hospital discharge or 7 days post surgery, whichever came first ]
  • 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

  • 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

  • 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

  • Length of Stay (Index Hospitalization) [ Time Frame: Within 60 days post surgery ]
    Overall length of stay for the index hospitalization

  • Length of Stay (Rehospitalization, Including ED Visits) [ Time Frame: Within 60 days of randomization ]
    Compare frequency of readmissions between groups for any cause and AF-related hospitalizations

  • Outpatient Interventions [ Time Frame: Within 60 days of randomization ]
    Compare frequency of outpatient visits between groups for any cause and AF-related causes

  • AF- or Treatment-related Events [ Time Frame: Within 60 days of randomization ]
  • Cost (Hospital) [ Time Frame: Within 60 days of randomization ]
    Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups


Enrollment: 523
Study Start Date: May 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rhythm control

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

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 Name: Cordarone
Procedure: DC-cardioversion
DC-Cardioversion - frequency and duration determined by medical professional as medically needed
Other Name: Direct Current Cardioversion
Active Comparator: Rate control

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
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132767


  Show 23 Study Locations
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Richard Wiesel, MD Cardiothoracic Surgical Trials Network
Study Chair: Patrick T O'Gara, MD Cardiothoracic Surgical Trials Network
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Annetine Gelijns, Professor and Chair, Health Evidence and Policy, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02132767     History of Changes
Other Study ID Numbers: GCO 08-1078-00007
5U01HL088942-08 ( U.S. NIH Grant/Contract )
First Submitted: May 5, 2014
First Posted: May 7, 2014
Results First Submitted: September 30, 2016
Results First Posted: January 18, 2017
Last Update Posted: January 18, 2017
Last Verified: November 2016

Keywords provided by Annetine Gelijns, Icahn School of Medicine at Mount Sinai:
Heart surgery
Cardiac surgery
Coronary artery bypass
Mitral valve surgery
Aortic valve surgery
Atrial fibrillation
Atrial flutter
Cardiac arrhythmia
Valve surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Digoxin
Amiodarone
Adrenergic beta-Antagonists
Calcium Channel Blockers
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors