Heart failure MedDRA version: 18.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Entresto
Product Name: Entresto
Pharmaceutical Form: Coated tablet
Trade Name: Not available : ATC group C09
Pharmaceutical
Sponsors
University Hospital Toulouse
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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 • Patient participating in another biomedical research or with an active exclusion period • Pregnancy • Breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This biomedical study will compare the effect of Entresto® and angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II inhibitor on sympathic nervous system activity.;Primary end point(s): Sympathic neural activity as assessed by microneurography by inserting an electrode directly in contact with orthosympathic efferent fibers around fibular nerve;Timepoint(s) of evaluation of this end point: At the end of the study for each patient : between 3 and 12 weeks; Secondary Objective: - Evaluation of disease severity (NYHA stage) in the two groups at the inclusion and after the treatment period. - Evaluation of impact of treatment and comparator on NTpro-BNP blood serum levels after the treatment in comparaison with inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): disease severity as assessed by NYHA stage and NT-proBNP serum levels;Timepoint(s) of evaluation of this end point: At the end of the study for each patient : between 3 and 12 weeks | — |
Countries
France
Contacts
Public ContactCaroline Peyrot
University Hospital Toulouse
Outcome results
None listed