NL-OMON51414招募中2 期
IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion - SALVAGE
Amsterdam UMC0 个研究点目标入组 110 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age > 50 years
- •2. Mild to moderate AVS, defined as:
- •(a) aortic valve maximum velocity by continuous wave doppler > 2,0
- •(b) aortic valve area >1,0 cm2 as calculated by continuity equation,
- •(c) morphologic evidence of aortic valve thickening, sclerosis or
- •calcification.
排除标准
- •1. Bicuspid aortic valve
- •2. History of chest radiotherapy
- •3. History of rheumatic fever
- •4. Moderate to severe renal failure, defined as eGFR < 30 ml/min
- •5. Hyperparathyroidism
- •6. Paget*s disease
- •7. Diagnosis of (active) malignancy in last 5 years
- •8. Anticipated or planned aortic valve surgery in the next 6 months
- •9. Life expectancy <2 years
- •10. Chronic atrial fibrillation
- •11. Use of anticoagulant medication or dual antiplatelet therapy
- •12. Known hypersensitivity to fish and/or shellfish
- •13. Known hypersensitivity to soya
- •14. Malabsorption syndrome and/or chronic diarrhea
- •15. Any other treatment or clinically relevant condition that could interfere
- •with the conduct or interpretation of the study in the opinion of the
- •investigator
- •16. Inability or unwillingness to comply with the protocol requirements, or
- •deemed by investigator to be unfit for the study
研究者
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