NCT02604745

Degenerative Mitral Regurgitation in Intermediate Risk Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

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 description

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 important information with which to guide patient care after mitral valve surgery.

Conditions

• Mitral Valve Insufficiency
• Mitral Regurgitation

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-12-01
• Completion: 2021-01-01
• First posted: 2015-11-13
• Last updated: 2021-04-01

Locations

1 site across 1 country: United States