Left Atrial Volume Index - Impact on LV Remodeling, LV Function and Functional Capacity in Asymptomatic Aortic Valve Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Functional Capacity
研究概览
简要总结
Aortic stenosis results in increased filling pressures of the heart. Size and function of the left atrium may be a marker for more advanced heart disease (heart failure) in patients with severe aortic stenosis, not presenting any apparent symptoms.
The goal of this study is to establish the importance and possible implications of left atrial dilation in asymptomatic patients with aortic valve stenosis.
详细描述
Aortic valve stenosis (AS) is the most common valvular disease in the western world. Mild and moderate AS generally is well tolerated severe AS is associated with considerable morbidity and mortality.
The consequence of AS is increased pressure load on the left ventricle, which causes changes in the ventricular function and structure (Left ventricular remodeling, hypertrophy, fibrosis).
With longstanding elevated filling pressures the left atrium will dilate and heart failure symptoms will develop.
When apparent, symptoms of heart failure, in AS are associated with high mortality rate and aortic valve replacement (AVR) is recommended.
The clinical assessment of heart failure symptoms in AS is however challenging particularly in the elderly, as symptoms progress slowly and may mimic age related fragility.
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
- •Asymptomatic severe aortic stenosis (Vmax > 3.5 m/sec and aortic valve area < 1 cm2).
排除标准
- •Moderate LV systolic dysfunction (LVEF < 50%)
- •Concomitant moderate-severe aortic valve regurgitation
- •Concomitant moderate-severe mitral valve regurgitation
- •Moderate to severe nephropathy
- •Chronic or persistent atrial fibrillation
- •Implanted pacemaker or cardio defibrillator
- •Disability to exercise testing.
结局指标
主要结局
Functional Capacity
时间窗: 2 years
Differences in functional capacity reflected by atrial size. An incremental maximal exersice test to determine maximal whole-body oxygen uptake (VO2-max) will be performed. On a cycle ergometer VO2 and VCO2 are measured continuously with a breath-by-breath pulmonary exchange system. Following the warm up, the resistance is increased every 2 minutes for 3 bouts, where after the resistance increases every minute (10% increments in VO2-max). The test is terminated 30 seconds after the subjects are unable to maintain 60 revolutions pr. min, but are still able to bike. A horizontal plateau on the oxygen uptake graph demarks the maximal oxygen uptake in liters pr. min. This is divided by their body mass, to obtain maximal oxygen uptake pr. mass unit pr. time unit.
次要结局
未报告次要终点
研究者
Nicolaj Lyhne Christensen
MD
Odense University Hospital