Clinical Trial: Degenerative Mitral Regurgitation in Intermediate Risk Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Degenerative Mitral Regurgitation in Intermediate Risk Patients 65 or Older: Exercise Echocardiogram and HRQOL Post Surgery Preliminary Analysis

Brief Summary: The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for degenerative mitral regurgitation.

Detailed Summary:

Severe mitral regurgitation is associated with significant morbidity and mortality. Mitral valve surgical repair has proven to be an effective and durable option in the treatment of symptomatic degenerative mitral regurgitation (MR).

Echocardiography remains a cornerstone in the evaluation of patients with degenerative (Type II) mitral regurgitation allowing for assessment of mitral anatomy, quantification of regurgitant severity, assessment of biventricular function, non-invasive measurement of pulmonary artery systolic pressures and identifying the presence of other valvular disease. The AHA/ACC Valvular Heart Disease Guidelines recommend the use of exercise echocardiography in the setting of mitral regurgitation to determine the degree of mitral regurgitation and pulmonary artery systolic pressures pre and post exercise in addition to an objective determination of the symptoms and exercise capacity.

Echocardiography (both resting and exercise modalities) is helpful in the post-mitral valve repair period in the assessment of the mitral valve gradient and recurrent mitral regurgitation. Symptomatic MR patients can have poor health-related quality of life (HRQOL) which improves and / or returns to comparable age-adjusted norms for reference populations after mitral valve repair or replacement.

To date, there is limited assessment of the degree of mitral regurgitation, mitral stenosis, and exercise capacity following both surgical and percutaneous mitral valve intervention as measured by exercise echocardiography. We propose that this modality with the addition of novel imaging technologies will provide a robust avenue for the assessment of these patients longitudinally. Additionally, assessment of HRQOL, including both the physical and mental health domains, will provide im
Sponsor: Northwestern University

Current Primary Outcome: Exercise Capacity [ Time Frame: 6 to 36 months Post Index Procedure ]

To evaluate exercise duration and workload (METS) in patients who have undergone mitral valve surgery for degenerative mitral regurgitation


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in HRQOL [ Time Frame: Baseline (Index procedure) up to 36 months after surgery ]
    To determine HRQOL changes from baseline to intermediate term (6 to 36 months) in intermediate risk patients undergoing surgery for Degenerative Mitral Regurgitation
  • Change in mitral regurgitation [ Time Frame: Pre-procedure up to 36 months after surgery ]
    To determine change in the degree of mitral regurgitation


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: November 10, 2015
Date Started: March 2016
Date Completion: December 2017
Last Updated: December 16, 2016
Last Verified: December 2016