Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls
研究概览
简要总结
Aortic stenosis (AE) is a disease that has been increasing steadily in recent years in most countries, including Spain.Risk factors for the development of AE include age, hypercholesterolemia, diabetes mellitus and arterial hypertension, the classic risk factors for the development of atherosclerosis. However, lipid-lowering therapy with statins and ezetimibe has not been shown to reduce the risk of long-term progression of AE by unknown mechanisms. All this suggests that subjects with HFhe have a high risk of developing AD, which has not been shown by the high coronary mortality in this population that precedes aortic calcification
详细描述
The study includes a single clinical visit with collection of clinical data, blood extraction and the performance of a transthoracic echocardiogram. This visit may be made on different days, but always within 30 days of signing the informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 65 years at the time of cardiac ultrasound
- •Genetically diagnosed HFH or in a first-degree relative
- •History of hypercholesterolemia with LDLc levels> 220 mg / dL without lipid-lowering treatment
- •Genetically Similar
- •Siblings of the normoccholesterolemic case, defined by LDLc <190 mg / dl without lipid-lowering treatment.
- •In the absence of available siblings, first cousins may be included.
- •In the presence of several siblings available, the same sex will be included,
- •Environmentally similar
- •Stable partner of the case with cohabitation> 25 years * Each case will have at least one control.
排除标准
- •Personal history of cardiac rheumatic disease
结局指标
主要结局
Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls
时间窗: 1 YEAR
次要结局
- Difference in aortic surface between cases and controls(1 YEAR)
- Difference in the mean transvalvular gradient between cases and controls(1 YEAR)
- Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls(1 YEAR)
- Difference between maximum aortic jet velocity between cases and controls(1 YEAR)
研究者
Fernando Civeira
Instituto Aragonés de Ciencias de la Salud
Instituto Aragones de Ciencias de la Salud