Evaluation of the Entresto Effect on Sympathic Nervous System in Patient With Heart Failure

Heart Failure Clinical Trial

— B2AN-SNS  

Official title:

Evaluation of the Effect of Double Inhibition of Angiotensin II AT1 Receptor and Neprilysin Activity on Sympathic Nervous System Activity in Patient With Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02787798
• Other study ID #: RC31/15/7746
• Status: Terminated
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: February 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 study, in the drug use conditions provided in the summary of product characteristics based on European marketing authorization (indications and dosage), the effect of the Entresto® on the activity of sympathic nervous system using the reference method, the microneurographic recording of sympathetic activity in muscle destiny (MSNA). This study will try to determine if the double inhibition of AT1 receptor and neprilysin activity result in lower sympathic nervous system burst rate versus single AT1 receptor inhibition using angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II inhibitor.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• valsartan/sacubitril 100 mg
Treatment with 100 mg tablets during 2 to 4 weeks
• valsartan/sacubitril 200 mg
Treatment with 200 mg tablets during 2 to 4 weeks

Procedure:
• Microneurography
Microneurography recording of sympathetic nervous system activity in muscle destiny

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of sympathetic nervous system activity as assessed by microneurography recording recording of sympathetic activity in muscle destiny	Evaluation of sympathetic nervous system activity in burst/minute	Up to 8 weeks
Secondary	Evaluation of severity of heart failure	assessed by New York Heart Association stage	Day 0
Secondary	Evaluation of severity of heart failure	assessed by New York Heart Association stage	Day 2
Secondary	Evaluation of severity of heart failure	assessed by New York Heart Association stage	Up to 4 weeks
Secondary	Evaluation of severity of heart failure	assessed by New York Heart Association stage	Up to 8 weeks
Secondary	Comparison of treatment effect on pro-brain natriuretic peptide serum levels at baseline and at the end of treatment period	pro-brain natriuretic peptide serum levels	Day 0 and up to 8 weeks