Clinical Trial Results:
Evaluation of the effect of double inhibition of angiotensin II AT1 receptor and neprilysin activity on sympatic nervous system activity in patient with heart failure (B2AN-SNS)
Summary
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EudraCT number |
2016-001124-66 |
Trial protocol |
FR |
Global end of trial date |
11 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Jul 2022
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First version publication date |
13 Jul 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
15774603
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02787798 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
CHU de Toulouse
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Sponsor organisation address |
2 rue de Viguerie, Toulouse, France, 31500
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Public contact |
Caroline PEYROT (chef de projet), CHU de Toulouse, +33 056177078486, peyrot.c@chu-toulouse.fr
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Scientific contact |
Michel GALINIER, University Hospital Toulouse, +33 0561323661, galinier.m@chu-toulouse.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Jan 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Jan 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Jan 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
A research oversight committee composed of the principal investigator and the head of the ANSM registration laboratory is planned.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Nov 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 4
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Worldwide total number of subjects |
4
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EEA total number of subjects |
4
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
4
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients will be recruited from the Cardiology Department of the University Hospital. | ||||||||||||||||||
Pre-assignment
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Screening details |
During the patient follow-up the investigating physician informs the patient and answers all his or her questions concerning the objective, the nature of the constraints, the foreseeable risks and the expected benefits of the research. He also specifies the patient's rights in the context of biomedical research and verifies the eligibility criteria | ||||||||||||||||||
Period 1
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Period 1 title |
overall period
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||
Blinding implementation details |
Patients are randomized and only the investigator in charge of recording sympathetic activity by MSNA (primary endpoint) will be blinded to the treatment received. Patients will also be blinded to the study arm in which they will be placed.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Entresto group | ||||||||||||||||||
Arm description |
Patients in this group receive Enteresto treatment. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
PR1 ( ENTRESTO)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
The initial dosage (100 mg: 49 mg sacubitril and 51 mg valsartan twice daily) will be valsartan twice daily) will be doubled and the patient will be reviewed at V3, 4-8 weeks after initiation of
initiation of treatment.
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Arm title
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Control group | ||||||||||||||||||
Arm description |
Patients receiving an active comparator instead of Enteresto. Sympathetic activity will be recorded by MSNA after 14 days of stable treatment with the active comparator, whose dosage is the same as for the experimental group. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
PR2 (C09)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
no comment about that
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Baseline characteristics reporting groups
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Reporting group title |
Entresto group
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Reporting group description |
Patients in this group receive Enteresto treatment. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control group
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Reporting group description |
Patients receiving an active comparator instead of Enteresto. Sympathetic activity will be recorded by MSNA after 14 days of stable treatment with the active comparator, whose dosage is the same as for the experimental group. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Entresto group
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Reporting group description |
Patients in this group receive Enteresto treatment. | ||
Reporting group title |
Control group
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Reporting group description |
Patients receiving an active comparator instead of Enteresto. Sympathetic activity will be recorded by MSNA after 14 days of stable treatment with the active comparator, whose dosage is the same as for the experimental group. |
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End point title |
Muscle destined sympathetic activity (MSNA) [1] | |||||||||
End point description |
The primary endpoint is muscle destined sympathetic activity (MSNA) measured by microneurography.
The recording is made with a tungsten microelectrode (200 µm in diameter), inserted in contact with the efferent orthosympathetic fibers that run around the
fibular nerve. A reference microelectrode is inserted subcutaneously at a distance of 2-3 cm from the measuring microelectrode.
measurement microelectrode.
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End point type |
Primary
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End point timeframe |
During all the study.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Lack of inclusion |
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Notes [2] - no results analysable [3] - no results analysable |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From patient consent signature until 7 days after the end of the participation of the patient.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
NA
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: no adverse events reported |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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05 Jan 2017 |
- Removal of the non-inclusion criterion "Patient treated with a statin".
- Elimination of plasma catecholamines during blood tests.
- Extension of the duration of inclusions.
- Modification of the information notice. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
no results avaiblable in this study. |