Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression of peak aortic jet velocity over one year (m/s per year)
研究概览
简要总结
Aortic stenosis is the most common valvular heart disease and an important public-health problem. Surgical or interventional aortic valve replacement are based on symptoms and measures of valvular and ventricular function using echocardiography.There is no uniform pattern of progression. Instead, marked differences not only between individuals, but also during the time course of the disease can be observed.
Several prospective studies have been performed to enhance the predictability of disease behavior. Individually it is still prone to large errors and hard to predict aortic stenosis progression. Therefore, in patients with aortic sclerosis without severe stenosis, it is desirable to find a strong predictor of rapid disease progression. This would allow anticipating cardiovascular deterioration by identifying individuals at particular risk.
Study Hypothesis
In patients with aortic sclerosis, increased serum calcification propensity, as measured by the T50-Test, is related to the amount of stenosis progression in one year.
详细描述
Background
Clinical Background
Aortic stenosis is the most common valvular heart disease and an important public-health problem. It is present in approximately 25% of all adults aged >65 years. Decisions about surgical or interventional aortic valve replacement are based on symptoms and measures of valvular and ventricular function using echocardiography. Such valvular affections are the result of a chronic progressive disease, usually starting with hemodynamically non-significant aortic sclerosis, and then progressing to severe stenosis over years. There is no uniform pattern of progression. Instead, marked differences not only between individuals, but also during the time course of the disease can be observed. Aortic sclerosis progresses to mild aortic stenosis in <15% of patients over 2 to 7 years. Once moderate stenosis is present (jet velocity >3 m/s), the average progression is 0.3 m/s per year, but still highly variable. When peak jet velocity exceeds 4 m/s, survival free from symptoms and valve replacement is significantly reduced.
In the past, several prospective studies have been performed to enhance the predictability of disease behavior. Some determinants of rapid progression and adverse outcome have been identified, such as: age, gender, cardiovascular risk factors, B-natriuretic peptide, stenosis severity, degree of valvular calcification and others. Although it appears that progression is more rapid in degenerative calcific disease than congenital or rheumatic disease, predicting progression individually is still prone to large errors even when considering these determinants. Therefore, regular clinical follow-up is mandatory in patients with asymptomatic aortic valve affections. In patients with aortic sclerosis without severe stenosis, it is desirable to find a strong predictor of rapid disease progression. This would allow anticipating cardiovascular deterioration by identifying individuals at particular risk.
Background of Tissue Calcification
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patient referred to routine clinical echocardiography
- •Aortic sclerosis with or without stenosis
- •Written informed consent
排除标准
- •Age <18 years
- •Aortic valve replacement scheduled within 1 year after inclusion
- •Any aortic valvular disease other than degenerative sclerotic, bi- or unicuspid valves
- •Known disease with expected survival <1 year
- •Known malignant tumor
- •Subvalvular obstruction (in left ventricular outflow tract) with mean pressure gradient >10mmHg
研究组 & 干预措施
All patients
Compare patients with high calcification propensity do have faster valve-stenosis progression
干预措施: no intervention (Other)
结局指标
主要结局
Progression of peak aortic jet velocity over one year (m/s per year)
时间窗: One year
次要结局
- Progression of peak aortic jet velocity >20% in one year(One year)
- Combined endpoint: death, hospitalizations, aortic-valve replacement, heart failure, angina, syncope(One year)