Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Annetine Gelijns, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT02132767
First received: May 5, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Total number of days in hospital [ Time Frame: Within 60 days of randomization ] [ Designated as safety issue: No ]
    The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.


Secondary Outcome Measures:
  • AF- or treatment-related events [ Time Frame: Within 60 days of randomization ] [ Designated as safety issue: No ]
  • Time to conversion to sustained, stable non-AF rhythm [ Time Frame: Up to 60 days post surgery ] [ Designated as safety issue: No ]
  • Heart rhythm comparison [ Time Frame: Hospital discharge and 30 days ] [ Designated as safety issue: No ]
    Compare heart rhythm at hospital discharge and at 30 days after surgery

  • Heart rhythm comparison [ Time Frame: Hospital discharge and 60 days ] [ Designated as safety issue: No ]
    Compare heart rhythm at hospital discharge and at 60 days after surgery

  • Length of Stay (index hospitalization) [ Time Frame: Within 60 days post surgery ] [ Designated as safety issue: No ]
    Overall length of stay for the index hospitalization

  • Length of Stay (rehospitalization, including ED visits) [ Time Frame: Within 60 days of randomization ] [ Designated as safety issue: No ]
    Compare frequency of readmissions between groups for any cause and AF-related hospitalizations

  • Outpatient Interventions [ Time Frame: Within 60 days of randomization ] [ Designated as safety issue: No ]
    Compare frequency of outpatient visits between groups for any cause and AF-related causes

  • Cost (hospital) [ Time Frame: Within 60 days of randomization ] [ Designated as safety issue: No ]
    Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups


Estimated Enrollment: 470
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02132767

Contacts
Contact: Kinjal Shah, PA-C 212-659-8399 kinjal.shah@mountsinai.org
Contact: Annetine C Gelijns, PhD 212-659-9567 annetine.gelijns@mssm.edu

  Show 23 Study Locations
Sponsors and Collaborators
Mount Sinai School of Medicine
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Timothy J Gardner, MD Cardiothoracic Surgical Trials Network
Study Chair: Patrick T O'Gara, MD Cardiothoracic Surgical Trials Network
  More Information

Additional Information:
No publications provided

Responsible Party: Annetine Gelijns, Professor and Chair, Health Evidence and Policy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT02132767     History of Changes
Other Study ID Numbers: GCO 08-1078-00007, 5U01HL088942-08
Study First Received: May 5, 2014
Last Updated: May 5, 2014
Health Authority: United States: Federal Government
Canada: Canadian Institutes of Health Research

Keywords provided by Mount Sinai School of Medicine:
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:
Arrhythmias, Cardiac
Heart Diseases
Atrial Fibrillation
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Amiodarone
Digoxin
Calcium Channel Blockers
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Enzyme Inhibitors
Vasodilator Agents
Membrane Transport Modulators
Cardiotonic Agents
Protective Agents

ClinicalTrials.gov processed this record on July 31, 2014