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Clinical Trials/EUCTR2016-001124-66-FR
EUCTR2016-001124-66-FR
Active, not recruiting
Phase 1

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 sites50 target enrollmentMarch 21, 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospital Toulouse
Enrollment
50
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 21, 2016
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity Hospital Toulouse

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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