Clinical trial NCT02132767: Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Official title: Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Atrial Fibrillation
Keywords: Heart surgery
Cardiac surgery
Coronary artery bypass
Mitral valve surgery
Aortic valve surgery
Atrial fibrillation
Atrial flutter
Cardiac arrhythmia
Valve surgery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-05-07
Enrollment: 523
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Number of Days in Hospital
timeFrame: Within 60 days of randomization
Secondary outcomes:
measure: Time to Conversion to Sustained, Stable Non-AF Rhythm
timeFrame: Up to index hospital discharge or 7 days post surgery, whichever came first
measure: Heart Rhythm Comparison
timeFrame: Hospital discharge
measure: Heart Rhythm Comparison
timeFrame: 30 days after randomization
measure: Heart Rhythm Comparison
timeFrame: 60 days after randomization
measure: Length of Stay (Index Hospitalization)
timeFrame: Within 60 days post surgery
measure: Length of Stay (Rehospitalization, Including ED Visits)
timeFrame: Within 60 days of randomization
measure: Outpatient Interventions
timeFrame: Within 60 days of randomization
measure: AF- or Treatment-related Events
timeFrame: Within 60 days of randomization
measure: Cost (Hospital)
timeFrame: Within 60 days of randomization
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Bethesda
country: United States
facility: NIH Heart Center at Suburban Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health Services
state: Michigan
city: Bronx
country: United States
facility: Montefiore Einstein Heart Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Study officials:
affiliation: Cardiothoracic Surgical Trials Network
name: Richard Wiesel, MD
role: STUDY_CHAIR
affiliation: Cardiothoracic Surgical Trials Network
name: Patrick T O'Gara, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.