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SMR Patient Abstract

STUDY TITLE: EVALUATION OF OUTCOMES FOLLOWING MITRAL VALVE REPAIR/REPLACEMENT IN SEVERE CHRONIC ISCHEMIC MITRAL REGURGITATION

Current Status: Enrollment Complete

What is the purpose of this research?
The purpose of this research is to determine whether it is better to repair or replace the mitral valve of patients with severe mitral valve leakage (regurgitation) from coronary artery disease. There are no new or “experimental” procedures being tested in this study and fixing the mitral valve is standard practice in patients with severe mitral regurgitation. What is not known is whether patients will benefit more when the valve is replaced with a new valve or repaired with a surgical ring. The available evidence addressing this issue has not been obtained through planned experiments such as this one, but rather from observations of the results of the two approaches that are both widely recommended and performed. These observations have produced conflicting results. At this point, the medical community is split in their opinion of how to treat the mitral valve in this circumstance. The aim of this carefully planned study is to resolve this question and ensure that all patients with your condition get the best procedure.

Who can be in this study?
People who have mitral valve leakage, which may be severe, may take part in this research study. The study is being conducted in 10 major medical centers in the United States and Canada and the plan is to enroll 250 patients in total.

Who cannot be in this study?
Some reasons a person may not be able to participate in this research study include:
Prior mitral valve repair, advanced liver, kidney, or heart disease, or having a heart attack within one week of study enrollment.

What procedures will be followed?
Once a patient has agreed to participate in the study and signed an informed consent document, the study will proceed in the following stages.

First you will be asked to perform several tests, including a cardiopulmonary exercise test, which measures your body’s ability to use oxygen during exercise, and an echocardiogram, which will take an ultrasound (sound wave) picture of your heart. Because the echocardiogram is the standard of care for these surgical procedures, you would undergo this test regardless of whether or not you participate in the study. The amount of mitral valve leakage observed on your echocardiogram will determine whether or not you are eligible to participate in this study. If the leakage is severe, you are eligible to participate and will be scheduled for a physical exam, blood tests, neurocognitive tests and asked to complete surveys about their past medical history, medication history, and quality of life.

Assignment to receiving either the mitral valve repair or replacement will occur while you are in the operating room and will be made by a scientific process (which involves random assignment, much like a coin toss). A scientific process is used to help make sure that the patients assigned to the two treatment groups (mitral valve replacement and repair) are very similar. You have an equal chance of being assigned to mitral valve repair and mitral valve replacement. You will be notified about which mitral valve procedure you received after your surgery.

All participants will undergo standard general anesthesia for heart surgery and have an incision made to expose the heart. For patients who need coronary artery bypass grafting (CABG) surgery, it will be performed using standard surgical techniques using either an artery from the chest and or veins from the leg to bypass the clogged coronary arteries. Patients who are assigned to mitral valve repair will undergo a standard surgical repair, which will involve opening the heart and sewing a surgical ring to the mitral valve to limit its opening and prevent leakage. Patients assigned to mitral valve replacement will undergo a mitral valve replacement procedure, where a new valve is sewn into place and some of the native (original) valve structures are left in place. If, after beginning the operation the surgeon feels that the mitral valve repair would not adequately correct the leakage, the surgeon can switch over and perform a mitral valve replacement procedure. Also, in some instances, a tricuspid valve repair will also be needed and performed by the surgeon. The steps in performing each of the operations are standard of care and would be performed in the manner described here whether or not you were enrolled in the study. An optional part of this research is to collect blood, urine and tissue for future studies.

After the surgery, all patients, regardless of whether their valve was repaired or not, will be asked to return for an outpatient evaluation at 30 days and then again at 6, 12, and 24 months. These evaluations will consist of a medication history, a physical exam, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality-of-life surveys. The echocardiogram is the only test that would be performed regardless of whether or not you are in the study. All data that is collected prior to, during, and after the surgery will then be sent to a data coordinating center at Mount Sinai School of Medicine for storage and analysis.

What are the possible risks of being in this study?
The research involves approved surgical procedures. The health risks for you are the same whether you 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. The results of this study should provide important information for the medical treatment for future patients with heart conditions 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 two years. You will be asked to return for an outpatient follow-up visit a total 4 times: at 30 days and 6, 12, and 24 months after surgery. Each visit will take approximately 2 hours, and during that time, you can expect to have a physical exam, a cardiopulmonary exercise tests, answer a quality of life survey, and have an ultrasound examination of your heart, called an echocardiogram. The echocardiogram will be performed regardless of your participation in this study.

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 for your medical care will be billed directly to you for payment.

You will not receive any compensation for your participation in this research study. You may receive a fixed amount of travel reimbursement to cover local travel expenses for your participation in study follow-up visits.

Who is funding this research?
This 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)

For any additional questions, you may send an email to the Mount Sinai Coordinating Center:
•  Ellen Moquete, RN, BSN, ellen.moquete@mountsinai.org, 212-659-9651 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/NCT00807040

GCO# 08-1078(2); Current annual IRB approval period: 10/10/17 - 10/9/18

Principal Investigator: Alan J. Moskowitz, MD