Prospective Study Looking at Quality of Life Measures in Non-ischaemic Cardiomyopathy After Mitral Valve Repair
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00483236|
Recruitment Status : Suspended (Lack of patient recruitment.)
First Posted : June 6, 2007
Last Update Posted : September 18, 2009
- Chronic severe mitral regurgitation can lead to symptoms and left ventricular dysfunction.
- The purpose of this study is to prospectively follow patients with non-ischaemic cardiomyopathy who are eligible for mitral valve repair surgery and primarily measure the quality of life through the Minnesota Living with Heart Failure Questionnaire & the Kansas City Cardiomyopathy Questionnaire.
|Condition or disease|
|Mitral Valve Insufficiency Dilated Cardiomyopathy, Congestive Heart Failure|
- Chronic mitral regurgitation (MR) usually spirals into a vicious cycle of left ventricular (LV) volume overload, LV dilatation, mitral annular dilatation and more MR. "MR begets MR". Eventually symptoms and LV dysfunction ensue. However, it can often be treated medically or surgically. Medical therapy is primarily afterload reduction and diuretics. Surgically, there are two options, either mitral valve repair or replacement.
- A number of retrospective studies have demonstrated improved LV function and survival in patients undergoing valve repair compared to valve replacement with or without subvalvular preservation. In one report, for example, patients who underwent valve repair were compared to patients who underwent valve replacement. The report found that the former group had lower operative mortality, a greater increase in LV ejection fraction and higher overall ten year survival.
- The bulk of the literature at present addresses left ventricular dimensions, ejection fraction, geometry and New York Heart Association functional class, but few have addressed quality of life measures. In addition, most of these studies were retrospective and the majority of patients had concomitant ischaemic heart disease.
- Even though the studies concerning quality of life after mitral valve surgery have been few, nevertheless, some have addressed isolated valve surgery without concomitant bypass surgery and have shown improved quality of life, though follow up in some was limited to 3 months. We will follow our population for 12 months after surgical repair.
- We will primarily look at subjective measures for quality of life such as the Minnesota Living with Heart Failure Questionnaire & the Kansas City Cardiomyopathy Questionnaire, as subjective measures are becoming more and more important following cardiac surgery. Patients will serve as their own controls and all study parameters will be compared pre- and post surgery.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Quality of Life Measures After Mitral Valve Repair in Non-Ischaemic Cardiomyopathy|
|Study Start Date :||December 2007|
|Estimated Study Completion Date :||June 2009|
- Quality of Life scores as measured by the Minnesota Living with Heart Failure Questionnaire & the Kansas City Cardiomyopathy Questionnaire [ Time Frame: 12 months ]
- 1- Echocardiographic parameters 2- 6 minute walk test 3- NYHA class 4- Hospitalisation for heart failure, redo surgery, morbidity & mortality [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483236
|Royal Victoria Hospital|
|Montreal, Quebec, Canada, H3A 1A1|
|Principal Investigator:||Nadia Giannetti, MD.,FRCPC||Director of Heart Failure and Transplant Centre at McGill University Health Centre|