Evaluation of the Entresto effect on sympatic nervous system in patient with heart failure (B2AN-SNS)

Phase 1

• Conditions: Heart failure; MedDRA version: 18.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-001124-66-FR
• Lead Sponsor: niversity Hospital Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-21
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br> Secondary Objective: - Evaluation of disease severity (NYHA stage) in the two groups at the inclusion and after the treatment period.<br><br> - Evaluation of impact of treatment and comparator on NTpro-BNP blood serum levels after the treatment in comparaison with inclusion.<br>

Secondary Outcome Measures

Name	Time	Method
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