Evaluation of the Entresto Effect on Sympathic Nervous System in Patient With Heart Failure (B2AN-SNS)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Nervous System, Cardiac disease
Eligibility Criteria
Inclusion Criteria:
Men or women with heart failure with symptomatic left ventricular systolic dysfunction (left ventricular ejection fraction ≤ 40 %) with :
- Functional class New York Heart Association II and at least 2 hospitalizations for cardiac decompensation in the year with N terminal pro brain-type natriuretic peptide ≥300 pg/ml (or brain-type natriuretic peptide ≥100 pg/ml) or usage of intravenous diuretics,
- Functional class New York Heart Association 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.
- Treated by maximum dosage of AT1 receptor of angiotensin II inhibitor or angiotensin-converting-enzyme inhibitor for New York Heart Association II patient or 50% of the recommended dose for New York Heart Association III-IV patients or New York Heart Association II patients with clinical manifestation restricting the use of maximum dosage, like orthostatic hypotension.
- Patient member of his home social security scheme
Exclusion Criteria:
- Patient who are receiving direct renin inhibitor like aliskiren
- Patient who are receiving phosphodiesterase 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
- Pregnancy
- Breast-feeding
Sites / Locations
- CHU de Toulouse
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Entresto
Control
Stop of all angiotensin-converting-enzyme inhibitor or antagonist of angiotensin II receptor during 2 days. valsartan/sacubitril 100 mg tablets (51 and 49 mg) during 2 to 4 weeks twice a day. valsartan/sacubitril 200 mg tablets (103 and 97 mg) during 2 to 4 weeks twice a day. Microneurography recording of sympathetic activity in muscle destiny (MSNA)
Hearth failure treatment as usual (angiotensin-converting-enzyme inhibitor or antagonist of angiotensin II receptor) Microneurography recording of sympathetic activity in muscle destiny (MSNA) will be done