Evaluation of the Entresto Effect on Sympathic Nervous System in Patient With Heart Failure
NCT02787798 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2019-02-07
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
Interventions
- DRUG
-
valsartan/sacubitril 100 mg
Treatment with 100 mg tablets during 2 to 4 weeks
- DRUG
-
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
Sponsors & Collaborators
-
University Hospital, Toulouse
lead OTHER
Principal Investigators
-
Michel Galinier, MD · University Hospital, Toulouse
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2018-01-31
- Completion
- 2018-01-31
Countries
- France
Study Locations
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