ISRCTN32424163已完成不适用
Effect of cholesterol lowering on progression of aortic stenosis in patients with mild to moderate aortic stenosis: a randomised controlled trial
niversity of Ottawa (Canada)0 个研究点目标入组 264 人开始时间: 2005年9月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 18 to 82 years
- •2. Both men and women will be included
- •3. At least mild AS defined by peak Doppler aortic valve velocity = 2.5 m/sec
- •4. Moderate risk for coronary artery disease (CAD), with low density lipoprotein cholesterol (LDL-C) less than 4 mmol/l and total cholesterol: high density lipoprotein cholesterol (HDL-C) ratio less than 6
- •5. Low risk for CAD with LDL-C less than 5 mmol/l and total cholesterol: HDL-C less than 7
排除标准
- •1. Peak Doppler aortic valve velocity less than 2.5 m/sec, because of the rate of progression in these patients is not well defined
- •2. Severe AS (a mean aortic gradient = 40 mmHg or AVA = 0.9 cm^2). These patients are excluded because they will have a high probability of aortic valve replacement even without further AS progression.
- •3. Symptomatic AS
- •4. Greater than moderate aortic regurgitation
- •5. Patients with significant concomitant mitral valve disease, defined by greater than moderate MR or MVA less than 2.0 cm^2
- •6. Patients on cholesterol lowering agents
- •7. Symptomatic coronary artery disease
- •8. Diabetes mellitus either on oral agent or insulin
- •9. At high or very high risks for CAD (10 year risk greater than 20%)
- •10. Moderate risk for CAD, but LDL-C greater than 4 mmol/l or total cholesterol: HDL-C ratio greater than 6
- •11. Low risk for CAD, but LDL-C greater than 5 mmol/l or total cholesterol: HDL-C ratio greater than 7
- •12. Pregnant or lactating women
- •13. Inability to return for follow up visits
- •14. Concomitant medical conditions, which limit the survival in the next 5 years
- •15. Inability or unwillingness to provide informed consent
研究者
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