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POAF Patient Abstract

STUDY TITLE: RATE CONTROL VERSUS RHYTHM CONTROL FOR POSTOPERATIVE ATRIAL FIBRILLATION

Current Status: Enrollment Complete

What is the purpose of this research?
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 your heart (atria) experiences disorganized electrical activity which causes your 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 your heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. The rate control strategy will attempt to slow your heart rate to less than 100 beats per minute at rest using medications known and approved to control heart rate. Both strategies are commonly used to treat AF. This research seeks to determine whether rhythm control is better than rate control in patients with AF after cardiac surgery.

Who can be in this study?
People who are undergoing heart surgery for coronary artery bypass and/or valve repair or replacement may take part in this research study.

Who cannot be in this study?
Some reasons a person may not be able to participate in this research study include: LVAD insertion (a mechanical pump that's used to support heart function and blood flow in people who have weakened hearts) or heart transplantation, prior maze procedure, Trans-apical TAVR(Trans catheter aortic valve replacement) , History of or planned mechanical valve replacement, Correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or PFO), History of Atrial fibrillation or Aflutter, History of ablation for Atrial fibrillation or Aflutter , Contraindications to warfarin or amiodarone, any need for long-term anticoagulation, Any other participation in an interventional (drug or device) trial.

Why is this study necessary?
Although both treatment options (rate and rhythm control) are effective and used regularly, there is not currently agreement among the community of cardiologists and cardiac surgeons as to which strategy for treating atrial fibrillation or atrial flutter after cardiac surgery is best. This study hopes to contribute to guidance for physicians and patients in the future.

What procedures will be followed?
In order to determine if you are eligible to participate, we will schedule you for a physical examination that will give us information about your general health. We will ask you questions about your past medical history and about the medications you are taking to confirm eligibility.

Once you have decided to participate in the study and signed this informed consent document, the study will proceed in the following stages.

You will then undergo the cardiac surgery for which you have previously been scheduled. It is standard practice to monitor the heart rhythm of all cardiac surgical patients after surgery. This will help to determine if you experience AF. If you do not experience AF within 7 days after your cardiac surgery, your participation in this study is complete. If you do experience AF within 7 days, you will be randomized to either rate or rhythm control to treat the AF.

The assignment to receive rate control or rhythm control will be determined using a process called randomization (which is much like flipping a coin). The chance that you will be selected to receive either rate control or rhythm control is 50%, or 1 out of 2. You and your doctors will know to which treatment you are assigned right away. You will begin being treated immediately after randomization. You will know which medications you are receiving.

Brief Description of Rate Control and Rhythm Control

Rate Control Strategy

If you are assigned to the Rate Control group, your doctor(s) will treat you with one or more approved medications for slowing your heart rate. These will include beta blockers such as metoprolol, atenolol, carvedilol or esmolol; calcium channel blockers such as diltiazem or verapamil; or digoxin. Your doctor will determine which dose and how long you will take these medications based on standard practices.

Rhythm Control Strategy

If you are assigned to the Rhythm Control group, your doctor(s) will treat you with amiodarone, a medication approved to control heart rhythm, for 60 days after randomization. You will either receive the amiodarone in pill form (400mg 3 times a day for 3 days, followed by 200mg per day until 60 days after randomization), or if you haven’t yet restarted eating after surgery you will receive the amiodarone by intravenous line (approximately 1000mg intravenously over the first 24 hours followed by 0.5mg/min until you can begin taking the drug in pill form).

If the amiodarone does not stop the AF within 48 hours, you will receive cardioversion as well. Cardioversion is a procedure in which an electric current is used to restore normal heart rhythm. Before the cardioversion procedure, you’ll be given medicine to make you sleep. A nurse or technician will stick soft pads called electrodes on your chest and possibly on your back. She/he may need to shave some areas on your skin to get the pads to stick. The electrodes will then be attached to a cardioversion machine. The machine will record your heart's electrical activity and send low-energy shocks through the pads to restore a normal heart rhythm.

If you are in the rhythm control group, you may also be treated with a rate control medication (for example, a beta blocker).

If your doctor determines that the strategy to which you were assigned is not treating your AF effectively and it is in your best interest, she/he may decide to switch you to the other treatment strategy. This would mean that if you were randomized to rate control, you would then be treated with rhythm control, or if you were randomized to rhythm control, you would then be treated with rate control.

You may receive warfarin, an anticoagulant medication (also known as a blood thinner), if your AF does not go away with treatment before you are discharged from the hospital, which would then continue for at least 60 days. A blood draw (5 mL or 1 teaspoon of blood) will be taken to measure the effect of the anticoagulation medication.

You will continue to be monitored during your inpatient hospital stay. This will include noting which medications you are taking and if you have received cardioversion during the hospitalization. An electrocardiogram or ECG (a reading of the electrical activity of your heart) will be performed before your discharge from the hospital.

Evaluation and Follow up visits

At 30 days and 60 days after randomization, you will receive an outpatient evaluation. At these evaluations, you will be given an ECG, asked about any hospitalizations or procedures you have received since your discharge, and asked about your health. You may return to the institution where you received your surgery for this visit, or the ECG may be obtained at your cardiologist’s office and then sent to the researchers for review and inclusion in your study record. If you do not have a regularly scheduled follow up appointment at the institution or with your cardiologist at 30 and 60 days, you will be asked to collect and transmit the ECG information using a device provided by the researchers, and the research team will follow-up by telephone with you to obtain the other information mentioned above.

All of your hospital charges will be collected from the hospital for the duration of the study. Allof your hospital charge data collected prior to, during, and after the surgery will be sent to the data coordinating center at Mount Sinai for storage and analysis without information that would identify you.

What are the possible risks of being in this study?
The research involves approved standard of care approach for treating atrial fibrillation or atrial flutter. The health risks for you are the same whether you take these medications or have these procedures as a participant in the research study or outside of the research study.

What are the possible benefits of being in this study?
You may or may not receive personal (direct) benefit from taking part in this study. You will receive the study prescribed treatment for AF if you experience it within 7 days after surgery. The possible benefits of taking part in this study include close monitoring by an experienced team, and the results of this study should provide important information for the medical treatment of AF for future patients undergoing cardiac surgeries similar to yours

How long will I be in the study?
If you choose to participate in the study, the expected time period during which you would be involved in the study would be 60 days.

What are the costs to be in this study?
Taking part in this study will not involve additional costs to you. All study specific tests will be paid for by the study sponsor.

You and/or your insurance company will have to pay for any costs that are part of your regular medical care. Anything not paid by your health insurance will be billed directly to you for payment.

Who is funding this research?
his research is being supported by a research grant from the following government programs:
•  National Heart, Lung, and Blood Institute (NHLBI)
•  National Institute of Neurological Disorders and Stroke (NINDS)
•  Canadian Institutes of Health Research (CIHR)
•  Portions of the Principal Investigator and his/her research team’s salaries are being paid by this grant.

For Further Information about the Study and Enrollment
If you are interested in participating in this research you may contact one of the CTSN participating sites. For contact information, please click here.

For any additional questions, you may send an email to the Mount Sinai Coordinating Center:
•  Kinjal Shah PA-C, kinjal.shah@mountsinai.org, 212-659-8399 or
•  Karen O’Sullivan, MPH, karen.o'sullivan@mountsinai.org, 212-659-9720

For more information about this study, please visit
http://clinicaltrials.gov/ct2/show/NCT02132767?term=RATE+CONTROL+VERSUS+RHYTHM+CONTROL+FOR+POSTOPERATIVE+ATRIAL+FIBRILLATION&rank=1

GCO# 08-1078(7); Current annual IRB approval period: 4/22/17 - 4/21/18

Principal Investigator: Annetine C. Gelijns, PhD