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临床试验/EUCTR2016-001124-66-FR
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:
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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

发起方
niversity Hospital Toulouse

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