The Effects of Degenerative Mitral Regurgitation on Cardiac Structure and Function, Symptoms, and Exercise Capacity
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in mitral regurgitant volume
研究概览
简要总结
Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.
详细描述
Current ACC/AHA guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. There are those who advocate for performing early "prophylactic" mitral valve surgery while others advocate clinical follow-up until triggers emerge with echocardiography historically being the method used for longitudinal assessment of cardiac anatomy and function. Two studies showed that only ~30% of asymptomatic severe mitral regurgitation made endpoints that triggered. However, these studies were limited and did not perform rigorous follow up assessment of regurgitant volume, left ventricular hemodynamics, exercise capacity, or quality of life assessment. In addition, in these studies mitral regurgitation and left ventricular size and function was assessed by echocardiography. Echocardiography has known limitations in assessing ventricular size and, as recent studies have shown, may not be the optimal modality to assess mitral regurgitant severity. MRI is the gold standard for non-invasive quantification of the left and right ventricles volumes and function and has emerged as a reference standard for quantifying mitral regurgitation. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=18 yrs
- •able to give informed consent
- •Diagnoses of moderate or severe degenerative mitral regurgitation (based on the integrated approach recommended by the American Society of Echocardiography)
排除标准
- •Left ventricular ejection fraction <60%
- •Heart failure
- •Pulmonary hypertension (pulmonary artery systolic pressure >40mmHg at rest or >60mmHg with exercise as assessed by echocardiography)
- •Atrial fibrillation
- •Concomitant > mild aortic or mitral stenosis, >mild aortic or tricuspid or pulmonic regurgitation
- •Prior valvular heart disease surgery
- •Hypertrophic cardiomyopathy or an infiltrative cardiomyopathy
- •Unable to exercise on a treadmill
- •Symptomatic coronary artery disease
- •Comorbidities expected to impact functional capacity and confound symptom assessment (e.g COPD)
- •Expected lifespan of less than 2 years
结局指标
主要结局
Change in mitral regurgitant volume
时间窗: Entry into study, 1 year, and 2 years
Change in mitral regurgitant volume quantified by MRI over follow-up period
次要结局
- Change in left ventricular end-diastolic volume(Entry into study, 1 year, and 2 years)
- Change in symptoms and quality(Entry into study, 1 year, and 2 years)
- Change in exercise capacity(Entry into study, 1 year, and 2 years)
- Follow up events(1 yea, and 2 years)
- Change in degree of myocardial fibrosis(Entry into study, 1 year, and 2 years)
研究者
Seth Uretsky
Medical Director, Cardiovascular Imaging
Atlantic Health System