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Evaluation of the Entresto Effect on Sympathic Nervous System in Patient With Heart Failure (B2AN-SNS)

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ClinicalTrials.gov Identifier: NCT02787798
Recruitment Status : Terminated (Today Entresto treatment has marketing authorization and is available for all patients, that is the reason why study was halted prematurely.)
First Posted : June 1, 2016
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE May 26, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date February 7, 2019
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
Evaluation of sympathetic nervous system activity as assessed by microneurography recording recording of sympathetic activity in muscle destiny [ Time Frame: Up to 8 weeks ]
Evaluation of sympathetic nervous system activity in burst/minute
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
  • Evaluation of severity of heart failure [ Time Frame: Day 0 ]
    assessed by New York Heart Association stage
  • Evaluation of severity of heart failure [ Time Frame: Day 2 ]
    assessed by New York Heart Association stage
  • Evaluation of severity of heart failure [ Time Frame: Up to 4 weeks ]
    assessed by New York Heart Association stage
  • Evaluation of severity of heart failure [ Time Frame: Up to 8 weeks ]
    assessed by New York Heart Association stage
  • Comparison of treatment effect on pro-brain natriuretic peptide serum levels at baseline and at the end of treatment period [ Time Frame: Day 0 and up to 8 weeks ]
    pro-brain natriuretic peptide serum levels
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
  • Evaluation of severity of heart failure as assessed by New York Heart Association stage [ Time Frame: Day 0 ]
  • Evaluation of severity of heart failure as assessed by New York Heart Association stage [ Time Frame: Day 2 ]
  • Evaluation of severity of heart failure as assessed by New York Heart Association stage [ Time Frame: Up to 4 weeks ]
  • Evaluation of severity of heart failure as 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 [ Time Frame: Day 0 and up to 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Entresto Effect on Sympathic Nervous System in Patient With Heart Failure
Official Title  ICMJE 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
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: valsartan/sacubitril 100 mg
    Treatment with 100 mg tablets during 2 to 4 weeks
    Other Name: Entresto 100 mg
  • Drug: valsartan/sacubitril 200 mg
    Treatment with 200 mg tablets during 2 to 4 weeks
    Other Name: Entresto 200 mg
  • Procedure: Microneurography
    Microneurography recording of sympathetic nervous system activity in muscle destiny
    Other Name: MSNA
Study Arms  ICMJE
  • 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)
    Interventions:
    • 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
    Intervention: Procedure: Microneurography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 5, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2016)
50
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787798
Other Study ID Numbers  ICMJE RC31/15/7746
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel Galinier, MD CHU Toulouse
PRS Account University Hospital, Toulouse
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP