Statin Therapy in Asymptomatic Aortic Stenosis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Progression of calcified aortic stenosis measured by:
研究概览
简要总结
There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially dependent on typical cardiovascular risk factors. An inflammatory process as well as those risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase inhibitors) would be an appealing concept to reduce both those risks for development of aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the progression of aortic stenosis.
详细描述
This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial trial to test the influence of statin therapy on the progression of calcified aortic stenosis in patients with asymptomatic mild to moderate aortic stenosis. After completion of all baseline investigations patients will be randomly assigned to the verum group (fluvastatin group) or to the control group (placebo group). Patients in the verum group will receive fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per day. The treatment should be continued until the study end (24 months). Follow up investigations will be performed after 6, 12, and 18 months. After 24 months the final investigations will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years
- •Mild to moderate aortic stenosis
- •No symptoms caused by aortic stenosis
- •Written informed consent to participate in the study
- •Aortic valve leaflet thickening with reduced systolic opening
- •Reduced aortic valve area > 0,8 cm2 and < 1,5 cm2
- •Maximum aortic jet velocity at rest > 2,5 m/s
排除标准
- •Symptoms caused by aortic stenosis
- •Aortic valve area < 0,7 cm2
- •Severe aortic regurgitation
- •Reduced left ventricular ejection fraction (< 50%)
- •Any valve disease with indication for surgery
- •Coronary artery disease
- •Therapy refractory arterial hypertension
- •Comorbid noncardiac diseases or other reasons which make a regular follow-up impossible
- •Other indication for treatment with statins
- •Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
- •Known sensitivity to study drug(s) or class of study drug(s)
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
- •Use of any other investigational agent in the last 30 days
结局指标
主要结局
Progression of calcified aortic stenosis measured by:
时间窗: 24 months
Transthoracic echocardiography (P max/ mean; V max; AVA)
时间窗: 24 months
Catheterization (peak to peak gradient, LV-function, compliance)
时间窗: 24 months
次要结局
- Number of cardiovascular events(24 months)