Protocol Number: 09-H-0050

Title:

Surgical Interventions for Moderate Ischemic Mitral Regurgitation

Number:

09-H-0050

Summary:

Background:

- To evaluate the outcomes of mitral valve repair or replacement in patients with moderate mitral valve leakage (regurgitation), researchers at the National Institutes of Health (NIH) will perform various tests to measure heart function before and after surgery.

Objectives:

- To record the results of echocardiograms and cardiopulmonary exercise testing in patients who are scheduled to have corrective surgery for moderate mitral valve regurgitation.

Eligibility:

- Patients 18 years of age and older who are scheduled to undergo surgery to repair or replace a defective mitral valve.

Design:

- Patients will come to NIH before the planned surgery to have an echocardiogram and cardiopulmonary exercise test on an outpatient basis.

- Cardiopulmonary exercise testing: Patients will be asked to exercise on a treadmill while wearing a face mask to measure heart rhythm, oxygen use rates, and blood pressure. The entire test will take approximately 1 hour.

- Echocardiography: Researchers will use ultrasound waves to take pictures of the heart. A complete baseline examination will be performed by a sonographer and evaluated by a physician. Patients may receive a small amount of an approved contrast agent (drug) to improve picture quality. The entire test will take approximately 1 hour.

- Patients will return to NIH at 6, 12, and 24 months after surgery to repeat the tests.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

The patient population for this trial consists of adult patients with moderate ischemic mitral regurgitation and clinically significant coronary artery disease with a clinical indication for coronary artery bypass grafting (CABG). All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity. All patients enrolled in the treatment study will undergo preoperative echocardiogram and cardiopulmonary stress testing at the NIH Clinical Center through the current protocol. For patients who are unable to come to the Clinical Center for medical reasons (determined by any of the investigators), the echocardiograms will be performed at Suburban Hospital. The patient's ability to transfer to the NIH for research studies will be determined based on recent heart failure, arrhythmia, hemodynamic, instability, inotropic support, or other condition deemed unstable for transfer by the physicians caring for the patient. Location of the study will be arranged with the Suburban Echo Lab and the patient's clinical providers.

The Inclusion Criteria for the CTSN protocol have been modified to use an integrative method to assess mitral regurgitation as specified below and on page 15 of the CT5N protocol.

-Moderate mitral regurgitation in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003:16:777-802). Quantitative guidelines as proposed would be: ERO between 0.2 cmsq to 0.39 cmsq. If ERO less than 0.2, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left

atrial area ratio, vena contracta, supportive criteria in an integrated fashion

Special Instructions:

Currently Not Provided

Keywords:

Ischemic Mitral Regurgitation

Coronary Artery Disease

Coronary Artery Bypass Grafting

Left Ventricular Remodeling

Recruitment Keyword(s):

Coronary Artery Disease

Coronary Artery Bypass Grafting

Mitral Valve

Condition(s):

Coronary Artery Disease

Mitral Regurgitation

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: CABG

Procedure/Surgery: MVR

Supporting Site:

National Heart, Lung, and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Arena R, Myers J, Williams MA, Gulati M, Kligfield P, Balady GJ, Collins E, Fletcher G; American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing. Assessment of functional capacity in clinical and research settings: a scientific statement from the American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology and the Council on Cardiovascular Nursing. Circulation. 2007 Jul 17;116(3):329-43.

Arena R, Peberdy MA, Myers J, Guazzi M, Tevald M. Prognostic value of resting end-tidal carbon dioxide in patients with heart failure. Int J Cardiol. 2006 May 24;109(3):351-8.

Arena R, Guazzi M, Myers J. Prognostic value of end-tidal carbon dioxide during exercise testing in heart failure. Int J Cardiol. 2007 Apr 12;117(1):103-8.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 11/25/2009