Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483236
Status:
WITHDRAWN
Last Update Posted:
2020-10-12
First Post:
2007-06-05
Brief Title:
Prospective Study Looking at Quality of Life Measures in Non-ischaemic Cardiomyopathy After Mitral Valve Repair
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Quality of Life Measures After Mitral Valve Repair in Non-Ischaemic Cardiomyopathy
Status:
WITHDRAWN
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None