Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

NCT ID: NCT02132767

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 523 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-09-30

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.

Conditions

Postoperative Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Amiodarone

Intervention Type: 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

DC-cardioversion

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

Rate Control

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

DC-cardioversion

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

Intervention Type: PROCEDURE

Rate Control

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

Intervention Type: DRUG

Other Intervention Names

Cordarone; Direct Current Cardioversion; Beta-blocker; Calcium channel blockers; Digoxin

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Annetine Gelijns

Professor and Chair, Health Evidence and Policy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Wiesel, MD

Role: STUDY_CHAIR

Cardiothoracic Surgical Trials Network

Patrick T O'Gara, MD

Role: STUDY_CHAIR

Cardiothoracic Surgical Trials Network

Locations

University of Southern California

Los Angeles, California, United States

Emory University

Atlanta, Georgia, United States

University of Maryland

Baltimore, Maryland, United States

NIH Heart Center at Suburban Hospital

Bethesda, Maryland, United States

University of Michigan Health Services

Ann Arbor, Michigan, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Montefiore Einstein Heart Center

The Bronx, New York, United States

Mission Hospital

Asheville, North Carolina, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Baylor Research Institute

Plano, Texas, United States

University of Virginia Health Systems

Charlottesville, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

University of Alberta Hospital

Edmonton, Alberta, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie de Quebec (Hopital Laval)

Québec, Quebec, Canada

Countries

United States; Canada

References

Afifi A. CTS trials network: Rate control vs rhythm control for atrial fibrillation after cardiac surgery - Do bitter pills have blessed effects? Glob Cardiol Sci Pract. 2016 Jun 30;2016(2):e201615. doi: 10.21542/gcsp.2016.15.

Reference Type: DERIVED

PMID: 29043263 (View on PubMed)

Gillinov AM, Bagiella E, Moskowitz AJ, Raiten JM, Groh MA, Bowdish ME, Ailawadi G, Kirkwood KA, Perrault LP, Parides MK, Smith RL 2nd, Kern JA, Dussault G, Hackmann AE, Jeffries NO, Miller MA, Taddei-Peters WC, Rose EA, Weisel RD, Williams DL, Mangusan RF, Argenziano M, Moquete EG, O'Sullivan KL, Pellerin M, Shah KJ, Gammie JS, Mayer ML, Voisine P, Gelijns AC, O'Gara PT, Mack MJ; CTSN. Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery. N Engl J Med. 2016 May 19;374(20):1911-21. doi: 10.1056/NEJMoa1602002. Epub 2016 Apr 4.

Reference Type: DERIVED

PMID: 27043047 (View on PubMed)

Related Links

http://www.ctsurgerynet.org/

Cardiothoracic Surgical Trials Network Website

Other Identifiers

5U01HL088942-08

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 08-1078-00007

Identifier Type: -

Identifier Source: org_study_id