Status:
TERMINATED
Evaluation of the Entresto Effect on Sympathic Nervous System in Patient With Heart Failure
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The hyperactivation of the sympathetic nervous system is a feature of the heart failure and the determinants of disease progression and risk of sudden cardiac death. This research project aims to stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02787798
Start Date
October 1 2016
End Date
January 1 2018
Last Update
February 7 2019
Active Locations (1)
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1
CHU de Toulouse
Toulouse, France