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.
Investigators
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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