Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

Postoperative Atrial Fibrillation Clinical Trial

Official title:

Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132767
• Other study ID #: GCO 08-1078-00007
• Secondary ID: 5U01HL088942-08
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Postoperative Atrial Fibrillation

Intervention

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

Procedure:
• DC-cardioversion
DC-Cardioversion - 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

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	Hôpital du Sacré-Cœur de Montréal	Montreal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Institut Universitaire de Cardiologie de Quebec (Hopital Laval)	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
United States	University of Michigan Health Services	Ann Arbor	Michigan
United States	Mission Hospital	Asheville	North Carolina
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	Montefiore Einstein Heart Center	Bronx	New York
United States	University of Virginia Health Systems	Charlottesville	Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	University of Southern California	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Baylor Research Institute	Plano	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Canadian Institutes of Health Research (CIHR), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Days in Hospital	The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.	Within 60 days of randomization
Secondary	Time to Conversion to Sustained, Stable Non-AF Rhythm		Up to index hospital discharge or 7 days post surgery, whichever came first
Secondary	Heart Rhythm Comparison	Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge	Hospital discharge
Secondary	Heart Rhythm Comparison	Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization	30 days after randomization
Secondary	Heart Rhythm Comparison	Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization	60 days after randomization
Secondary	Length of Stay (Index Hospitalization)	Overall length of stay for the index hospitalization	Within 60 days post surgery
Secondary	Length of Stay (Rehospitalization, Including ED Visits)	Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits	Within 60 days of randomization
Secondary	Outpatient Interventions	Compare frequency of outpatient visits between groups for any cause and AF-related causes	Within 60 days of randomization
Secondary	AF- or Treatment-related Events		Within 60 days of randomization
Secondary	Cost (Hospital)	Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups	Within 60 days of randomization

External Links

•   Cardiothoracic Surgical Trials Network Website