Heart FailurePhase 4B2AN-SNSNCT02787798
Evaluation of the Entresto Effect on Sympathic Nervous System in Patient With Heart Failure
A Phase 4 study testing valsartan/sacubitril 100 mg, valsartan/sacubitril 200 mg and Microneurography in people with Heart Failure, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- valsartan/sacubitril 100 mg, valsartan/sacubitril 200 mg and Microneurography
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Heart Failure
- Being tested
- valsartan/sacubitril 100 mg, valsartan/sacubitril 200 mg, Microneurography
- Keywords
- Nervous System, Cardiac disease
- Medical subject headings
- Heart Failure, Neurologic Manifestations, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartan/sacubitril 100 mgDrug
Also called Entresto 100 mg
Treatment with 100 mg tablets during 2 to 4 weeks
valsartan/sacubitril 200 mgDrug
Also called Entresto 200 mg
Treatment with 200 mg tablets during 2 to 4 weeks
MicroneurographyProcedure or surgery
Also called MSNA
Microneurography recording of sympathetic nervous system activity in muscle destiny
| Study group | Role | What they receive |
|---|---|---|
| Entresto | Experimental | * 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) Receives: Drug: valsartan/sacubitril 100 mg; Drug: valsartan/sacubitril 200 mg; Procedure: Microneurography |
| Control | Placebo comparator | * 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 Receives: Procedure: Microneurography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 8 weeks
Secondary outcomes (5)
Evaluation of severity of heart failure
assessed by New York Heart Association stage
Measured: Day 0
Evaluation of severity of heart failure
assessed by New York Heart Association stage
Measured: Day 2
Evaluation of severity of heart failure
assessed by New York Heart Association stage
Measured: Up to 4 weeks
Evaluation of severity of heart failure
assessed by New York Heart Association stage
Measured: 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
Measured: Day 0 and up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Today Entresto treatment has marketing authorization and is available for all patients, that is the reason why study was halted prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Galinier, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787798
- Sponsor's protocol ID
- RC31/15/7746
- Acronym
- B2AN-SNS
- Status last verified
- Feb 2019
- First submitted
- 26 May 2016
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02787798
- Acronym / sponsor ID
- B2AN-SNS / RC31/15/7746
- Conditions
- Heart Failure
- Keywords
- Nervous System, Cardiac disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Today Entresto treatment has marketing authorization and is available for all patients, that is the reason why study was halted prematurely.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entresto | Experimental | Drug: valsartan/sacubitril 100 mg, Drug: valsartan/sacubitril 200 mg, Procedure: Microneurography* 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) |
| Control | Placebo comparator | Procedure: Microneurography* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women with heart failure with symptomatic left ventricular systolic dysfunction (left ventricular ejection fraction ≤ 40 %) with :
- Patient member of his home social security scheme
Key exclusion criteria (12 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valsartan/sacubitril 100 mgAlso: Entresto 100 mgTreatment with 100 mg tablets during 2 to 4 weeks | Drug | Entresto |
| valsartan/sacubitril 200 mgAlso: Entresto 200 mgTreatment with 200 mg tablets during 2 to 4 weeks | Drug | Entresto |
| MicroneurographyAlso: MSNAMicroneurography recording of sympathetic nervous system activity in muscle destiny | Procedure or surgery | Control, Entresto |
Primary outcome
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
5 secondary outcomes
Evaluation of severity of heart failure
Time frame: Day 0
Evaluation of severity of heart failure
Time frame: Day 2
Evaluation of severity of heart failure
Time frame: Up to 4 weeks
Evaluation of severity of heart failure
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
Results and safety
The study was stopped early (reason given: Today Entresto treatment has marketing authorization and is available for all patients, that is the reason why study was halted prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Galinier, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan/sacubitril 100 mg, valsartan/sacubitril 200 mg and Microneurography in people with Heart Failure, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Today Entresto treatment has marketing authorization and is available for all patients, that is the reason why study was halted prematurely.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sympathetic nervous system activity as assessed by microneurography recording recording of sympathetic activity in muscle destiny (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.