EUCTR2016-001124-66-FR进行中(未招募)1 期
Evaluation of the effect of double inhibition of angiotensin II AT1 receptor and neprilysin activity on sympatic nervous system activity in patient with heart failure (B2AN-SNS)
niversity Hospital Toulouse0 个研究点目标入组 50 人开始时间: 2016年3月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Men or women of 18 years old or older with heart failure with symptomatic left ventricular systolic dysfunction (left ventricular ejection fraction = 40 %) with :
- •-Functional class NYHA II and at least 2 hospitalizations for cardiac decompensation in the year with NT-proBNP =300 pg/ml (or BNP =100 pg/ml) or usage of intravenous diuretics,
- •-Functional class NYHA III-IV,
- •-Insufficiently controlled by alternative drug-free therapies (surgery, cardiac resynchronization ...) or well managed drug therapies: angiotensin-converting-enzyme inhibitor, AT1 receptor of angiotensin II inhibitor diuretics or beta blockers.
- •Patient member of his home social security scheme
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Patient who are receiving direct renin inhibitor like aliskiren
- •Patient who are receiving a statin
- •Patient who are receiving phosphodiestérase V inhibitors
- •Patient who are receiving a potassium-sparing drug
- •Patient with medical history of angioedema with previous treatment by angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II inhibitor
- •Hypersensitivity to any component of Entresto®
- •Adult protected by the law
- •Severe renal impairment (DFGe <30 ml/min/1,73 m2)
- •Severe hepatic impairment, cirrhosis or cholestasis (Child-Pugh C class)
- •Patient with are receiving anticoagulant therapies or suffering from known hemostatic trouble
- •Patient participating in another biomedical research or with an active exclusion period
- •Breast-feeding
研究者
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