Prospective Study Looking at Quality of Life Measures in Non-ischaemic Cardiomyopathy After Mitral Valve Repair

This study has suspended participant recruitment.
(Lack of patient recruitment.)
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00483236
First received: June 5, 2007
Last updated: September 17, 2009
Last verified: September 2009
  Purpose
  • 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
Mitral Valve Insufficiency
Dilated Cardiomyopathy,
Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Measures After Mitral Valve Repair in Non-Ischaemic Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Quality of Life scores as measured by the Minnesota Living with Heart Failure Questionnaire & the Kansas City Cardiomyopathy Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1- Echocardiographic parameters 2- 6 minute walk test 3- NYHA class 4- Hospitalisation for heart failure, redo surgery, morbidity & mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2007
Estimated Study Completion Date: June 2009
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.
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Heart Failure Clinic

Criteria

Inclusion Criteria:

  • Patients that fulfill surgical criteria set by the 2006 ACC/AHA guidelines for the management of patients with valvular heart disease.
  • Symptomatic mitral regurgitation with left ventricular dysfunction (LVEF < or = 40%) on maximal medical therapy

Exclusion Criteria:

  • Mitral valve replacement
  • Concomitant coronary artery bypass surgery
  • Patient unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483236

Locations
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Nadia Giannetti, MD.,FRCPC Director of Heart Failure and Transplant Centre at McGill University Health Centre
  More Information

No publications provided

Responsible Party: Nadia Giannetti, MD, FRCPC, McGill University Health Centre
ClinicalTrials.gov Identifier: NCT00483236     History of Changes
Other Study ID Numbers: BMB-06-022
Study First Received: June 5, 2007
Last Updated: September 17, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Non-Ischaemic Cardiomyopathy

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Cardiomyopathy, Dilated
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Heart Valve Diseases

ClinicalTrials.gov processed this record on October 19, 2014