Beta-Blockade in Chronic Mitral Regurgitation: Moving From the Laboratory Experiment to Clinical Investigation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic Volumes
研究概览
简要总结
The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.
详细描述
The purpose of this study tests 1) whether Toprol xl, a beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation; 2) investigate the effects of chronic mitral regurgitation on left ventricular remodeling, left ventricular function,exercise capacity and clinical symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of sever primary mitral regurgitation
- •Normal subjects
排除标准
- •Left ventricle ejection fraction of <55% pre and post operation
- •Pregnancy or Lactation
- •Secondary mitral regurgitation due to coronary artery disease, cardiomyopathy, uncontrolled hypertension, or severe aortic stenosis.
研究组 & 干预措施
1
Patients who are asymptomatic with normal left ventricular systolic function and who agree to be treated medically for severe primary mitral regurgitation with Beta-blocker therapy. Patients may entered into the Arm 2 (surgical treatment) later on when they develop symptoms or enlarged left ventricle or left ventricular dysfunction or wishes to have surgical treatment of severe primary mitral regurgitation.
干预措施: Beta-blocker therapy (TOPROL-XL® ) (Drug)
结局指标
主要结局
Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic Volumes
时间窗: Baseline, 6 months
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling
Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic dimensions
时间窗: Baseline, 6 months
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling
Change on Neurohormonal Measurements
时间窗: Baseline, 6 months
Change is calculated as the value at 6 months minus the value at baseline. The following neurohormones are measured: Brain type Natriuretic Peptide (BNP), tumor necrosis factor- alpha ( TNF- alpha), norepinephrine, epinephrine and plasma renin activity.
Change in Left Ventricular Ejection Fraction
时间窗: Baseline, 6 months
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess the systolic function.
Change on Left Ventricular Mass
时间窗: Baseline, 6 months
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling
次要结局
- Change in Pulmonary Venous Systolic Flow Reversal(Baseline, 6 months)
- Change on the Regurgitant Stroke Volume(6 months)