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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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