TerminatedNCT02787798B2AN-SNSUpdated Feb 7, 2019

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

A Phase 4 interventional study of valsartan/sacubitril 100 mg and valsartan/sacubitril 200 mg in Heart Failure, sponsored by University Hospital, Toulouse. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by University Hospital, Toulouse · Phase 4, Interventional, and Treatment

Why this study was terminated

Today Entresto treatment has marketing authorization and is available for all patients, that is the reason why study was halted prematurely.

Phase: Phase 4
Study type: Interventional
Enrollment: 4
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Heart Failure

Browse trials for

Heart Failure 5,701

Keywords

Nervous System
Cardiac disease

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 4 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 4 participants (actual)

Study arms

Experimental
Entresto
* 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)
Drug: valsartan/sacubitril 100 mg · Drug: valsartan/sacubitril 200 mg · Procedure: Microneurography
Placebo comparator
Control
* 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
Procedure: Microneurography

Interventions

Drugvalsartan/sacubitril 100 mg
Treatment with 100 mg tablets during 2 to 4 weeks
Also known as: Entresto 100 mg
Drugvalsartan/sacubitril 200 mg
Treatment with 200 mg tablets during 2 to 4 weeks
Also known as: Entresto 200 mg
ProcedureMicroneurography
Microneurography recording of sympathetic nervous system activity in muscle destiny
Also known as: MSNA

What researchers measure

Primary outcomes

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
Time frame: Up to 8 weeks

Secondary outcomes

Evaluation of severity of heart failure
assessed by New York Heart Association stage
Time frame: Day 0
Evaluation of severity of heart failure
assessed by New York Heart Association stage
Time frame: Day 2
Evaluation of severity of heart failure
assessed by New York Heart Association stage
Time frame: Up to 4 weeks
Evaluation of severity of heart failure
assessed by New York Heart Association stage
Time frame: Up to 8 weeks
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
Time frame: Day 0 and up to 8 weeks

Study locations

1 site

CHU de Toulouse
Toulouse, France

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02787798
Lead sponsor: University Hospital, Toulouse
Responsible party: Sponsor
First posted: Jun 1, 2016
Start date: Oct 2016
Primary completion: Jan 2018
Completion: Jan 2018
Last update: Feb 7, 2019

Study contacts

Michel Galinier, MD

principal investigator · CHU Toulouse

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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