Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators:	Canadian Institutes of Health Research (CIHR) National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00807040

Purpose

People with coronary artery disease (CAD) or people who have had a heart attack may develop a leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the valve. The best way to fix the mitral valve remains undetermined. This study will evaluate whether it is better for people with severe mitral valve leakage to undergo a mitral valve replacement procedure or a mitral valve repair procedure.

Condition	Intervention	Phase
Mitral Valve Insufficiency Coronary Artery Disease	Procedure: Mitral Valve Repair with Annuloplasty Procedure: Mitral Valve Replacement	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Degree of left ventricular remodeling, as assessed by left ventricular end systolic volume index (LVESVI) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All-cause mortality [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.	Procedure: Mitral Valve Repair with Annuloplasty The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
Active Comparator: 2 Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.	Procedure: Mitral Valve Replacement Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.

Detailed Description:

CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup. In severe cases, CAD can cause chest pain, shortness of breath, and heart attack. After a heart attack, some people may develop a leak in the mitral valve of the heart. This condition is known as ischemic mitral regurgitation (IMR), and it can cause blood to flow backward into the heart. If left untreated, severe IMR can lead to heart failure or serious heart rhythm irregularities, known as arrhythmias. People with severe mitral valve leakage routinely undergo one of two surgical procedures to fix the mitral valve: a mitral valve repair procedure, in which a surgical ring is used to repair the valve; or a mitral valve replacement procedure, in which the damaged valve is replaced with a new one. Currently, there is no consensus in the medical community as to which procedure is more beneficial. The purpose of this study is to determine whether people with severe mitral valve regurgitation should undergo a mitral valve repair procedure or a mitral valve replacement procedure.

This study will enroll people with CAD who have severe mitral regurgitation. At a baseline study visit, participants will undergo a physical examination; blood collection; neurocognitive tests; and questionnaires regarding medical history, medication history, and quality of life. In the operating room, participants will be randomly assigned to undergo either the mitral valve repair procedure or the mitral valve replacement procedure. Blood, urine, and tissue samples may be collected from participants after the surgery; this is optional and will only be done with prior approval from participants. All participants will attend study visits at Day 30 and Months 6, 12, and 24. At each visit, participants will take part in a medication history review, a physical examination, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality of life surveys.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic severe ischemic mitral regurgitation (often with tethering as a major mechanism) 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. see appendix). Quantitative guidelines as proposed would be: ERO ≥ 0.4 cmsq. If ERO < 0.4, 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
Eligible for surgical repair and replacement of mitral valve
CAD with or without the need for coronary revascularization

Exclusion Criteria:

Any evidence of structural (chordal or leaflet) mitral valve disease or ruptured papillary muscle
Prior mitral valve repair
Severe irreversible pulmonary hypertension in the judgment of the investigator
Medically unable to undergo cardiopulmonary bypass (CPB)
Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography
Planned concomitant intra-operative procedures (with the exception of tricuspid valve repair, closure of patent foramen ovale [PFO] or atrial septal defect [ASD] or Maze procedure)
Clinical signs of cardiogenic shock at the time of surgery
Treatment with long-term intravenous inotropic therapy at the time of surgery
ST segment elevation myocardial infarction (MI) requiring intervention in the 7 days before surgery
Congenital heart disease (except PFO or ASD)
Evidence of cirrhosis or liver synthetic failure
Excessive surgical risk, as judged by the surgical investigator
Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, as judged by the investigator
Therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in this study
Any concurrent disease with a life expectancy of less than 2 years
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807040

Contacts

Contact: Annetine Gelijns, PhD	212-659-9568	annetine.gelijns@mssm.edu
Contact: Ellen Moquete, RN, BSN	212-659-9651	ellen.moquete@mountsinai.org

Locations

United States, California
University of Southern California	Recruiting
Los Angeles, California, United States, 90033
Contact: Michael Bowdish, MD 323-442-5849 michael.bowdish@med.usc.edu
Contact: Shadi Javadifar 323-442-6252 shadi.javadifar@med.usc.edu
Principal Investigator: Michael Bowdish, MD
United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30383
Contact: John Puskas, MD 404-686-2513 john_puskas@emoryhealthcare.org
Contact: Alexis Neill, RN 404-686-3575 alexis.neill@emoryhealthcare.org
Principal Investigator: John Puskas, MD
Wellstar Kennestone Hospital	Recruiting
Marietta, Georgia, United States, 30060
Contact: William A Cooper, MD 404-686-2513 William.cooper@emoryhealthcare.org
Contact: Tauri Harden, RN 678-594-4316 tauri.harden@wellstar.org
Principal Investigator: William A Cooper, MD
United States, Maryland
University of Maryland	Recruiting
Baltimore, Maryland, United States, 21201
Contact: James Gammie, MD 410-328-5842 jgammie@smail.umaryland.edu
Contact: Dana Beach, BSN, RN 410-328-0993 dbeach2@smail.umaryland.edu
Principal Investigator: James S Gammie, MD
NIH Heart Center at Suburban Hospital	Recruiting
Bethesda, Maryland, United States, 20892
Contact: Keith Horvath, MD 301-451-7098 khorvath@nih.gov
Contact: Mandy Murphy, RN 301-896-3775 mmurphy@suburbanhospital.org
Principal Investigator: Keith Horvath, MD
United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Frederick Y Chen, MD 617-732-7775 fchen@partners.org
Contact: Debra Conboy, RN 617-732-7019 daconboy@partners.org
Principal Investigator: Frederick Y Chen, MD, PhD
United States, Missouri
Washington University	Recruiting
St Louis, Missouri, United States, 63110
Contact: Ralph J Damiano, MD 314-362-7327 damianor@wudosis.wustl.edu
Contact: Tracey Guthrie, RN 314-747-4404 guthriet@wudosis.wustl.edu
Principal Investigator: Ralph J Damiano, MD
United States, New York
Montefiore Einstein Heart Center	Recruiting
Bronx, New York, United States, 10467
Contact: Robert E. Michler, MD 718-920-2100 rmichler@montefiore.org
Contact: Roger Swayze, RN 718-920-2221 rswayze@montefiore.org
Principal Investigator: Robert E. Michler, MD
Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Michael Argenziano, MD 212-305-5888 ma66@columbia.edu
Contact: Lyn Goldsmith, MA, RN, CCRC 212-342-0261 lg2240@columbia.edu
Principal Investigator: Michael Argenziano, MD
United States, North Carolina
Mission Hospital	Recruiting
Asheville, North Carolina, United States, 28801
Contact: Mark Groh, MD 828-258-1121 mgroh@ashevilleheart.com
Contact: Claudine Cuento, BSN, RN 828-213-7032 claudine.cuento@msj.org
Principal Investigator: Mark A Groh, MD
Duke University	Recruiting
Durham, North Carolina, United States, 27710
Contact: Peter Smith, MD 919-684-2890 smith058@mc.duke.edu
Contact: Stacey Welsh, RN stacey.welsh@duke.edu
Principal Investigator: Peter Smith, MD
East Carolina Heart Institute	Recruiting
Greenville, North Carolina, United States, 27834
Contact: T. Bruce Ferguson, MD 252-744-5232 Fergusont@ecu.edu
Contact: Malissa Harris, RN 252-744-5287 Harrismal@ecu.edu
Principal Investigator: T. Bruce Ferguson, MD
United States, Ohio
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Eugene Blackstone, MD 216-444-6712 blackse@ccf.org
Contact: Christine Whitman, RN, CCRC 216-445-6916 whitmac@ccf.org
Principal Investigator: Eugene Blackstone, MD
Sub-Investigator: Mark Gillinov, MD
Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Contact: Chittoor B Sai-Sudhakar, MBBS 614-293-9327 sai.sudhakar@osumc.edu
Contact: Danielle Jones, RN 614-366-8506 danielle.jones@osumc.edu
Principal Investigator: Chittoor B Sai-Sudhakar, MBBS
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael Acker, MD 215-349-8305 michael.acker@uphs.upenn.edu
Contact: Mary Lou Mayer, RN 215-662-7981 marylou.mayer@uphs.upenn.edu
Principal Investigator: Michael Acker, MD
United States, Texas
Baylor Research Institute	Recruiting
Plano, Texas, United States, 75093
Contact: Michael Mack, MD 469-814-4105 michaelma@baylorhealth.edu
Contact: Jennifer Withers, RN, CCRC 469-814-5691 jennw@baylorhealth.edu
Principal Investigator: Michael Mack, MD
United States, Virginia
University of Virginia	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Irving L. Kron, MD 434-924-2158 ilk@virginia.edu
Contact: Sandra Burks, RN 434-243-0315 sgb2c@virginia.edu
Principal Investigator: Irving L. Kron, MD
Inova Heart and Vascular Institute	Recruiting
Falls Church, Virginia, United States, 22042
Contact: Alan Speir, MD 703-280-5858 ext 1106 aspeir1@gmail.com
Contact: Minh Dang 703-776-6028 minh.dang@inova.org
Principal Investigator: Alan Speir, MD
Canada, Quebec
Montreal Heart Institute	Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Louis Perrault, MD, PhD 514-376-3330 louis.perrault@icm-mhi.org
Contact: Sophie Robichaud 514-376-3330 ext 3305 Sophie.Robichaud@icm-mhi.org
Principal Investigator: Louis Perrault, MD, PhD
Hôpital du Sacré-Coeur de Montréal	Recruiting
Montreal, Quebec, Canada, QC H4J 1C5
Contact: Pierre Pagé, MD 514-338-2222 ext 3246 pierre.page@umontreal.ca
Contact: Carole Sirois 514-338-2222 ext 3083 carole.sirois@crhsc.rtss.qc.ca
Principal Investigator: Pierre Pagé, MD
Canada
Quebec Heart Institute/Laval Hopital	Recruiting
Quebec, Canada, H7M 3L9
Contact: Pierre Voisine, MD 418 656-4717 pierre.voisine@chg.ulaval.ca
Contact: Gladys Dussault, RN 418-656-8711 ext 2765 gladys.dussault@criucpq.ulaval.ca
Principal Investigator: Pierre Voisine, MD

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Canadian Institutes of Health Research (CIHR)

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Study Chair:	Timothy Gardner, MD	Christiana Care Health System
Study Chair:	Patrick O'Gara, MD	Brigham and Women's Hospital

More Information

Additional Information:

Click here for the Cardiothoracic Surgical Trials Network Web site. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00807040 History of Changes
Obsolete Identifiers:	NCT00919256
Other Study ID Numbers:	595, U01 HL088942-01-2
Study First Received:	December 10, 2008
Last Updated:	September 26, 2011
Health Authority:	United States: Federal Government; Canada: Canadian Institutes of Health Research; Canada: Ethics Review Committee

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Ischemic Mitral Regurgitation
Mitral Valve Disease
Severe Mitral Regurgitation

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Mitral Valve Insufficiency
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on February 02, 2012