HypertensionNCT05462405
Evaluation of Sympathetic Activity Effects by the BackBeat Medical Cardiac Neuromodulation Therapy (CNT).
A study testing Experimental group in people with Hypertension, run by BackBeat Medical Inc at 1 site in Hungary.
Trial summary
Measurement and recording of Muscle Sympathetic Neural Activity (MSNA) using microneurography, will be applied to subjects who have been already implanted with a Moderato IPG delivering the BackBeat CNT and/or pacing signals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Experimental group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHungary
- Study dates
- 10 Dec 2022to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject is already implanted with a Moderato IPG that can be used to deliver CNT pacing signals, whether CNT pacing was activated or not.
- Subject is willing and able to comply with the study and procedures.
Who cannot join
- Subject is dependent on 100% ventricular pacing.
- Subject has symptoms of heart failure, NYHA Class III or greater.
- Subject has an ejection fraction of 25% or less
- Subject's systolic blood pressure is less than 100 mm Hg on the day of recording.
- Subject has decompensated heart failure
- Subject has significant (>3+) mitral regurgitation, aortic regurgitation, or aortic stenosis
Show all 14Show fewer
- Subject has permanent atrial fibrillation.
- Subject has Atrial fibrillation on the day of the study.
- Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy, or interventricular septal thickness ≥15 mm.
- Subject is on dialysis
- Subject has prior neurological events (stroke or TIA) within the past year or a neurological event (stroke) at any prior time that has resulted in residual neurologic deficit.
- Subject has a history of autonomic dysfunction.
- Women who are pregnant or breast-feeding.
- Subject cannot or is unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microneurography MSNA Measurements for Evaluating the Effect of BackBeat Medical Cardiac Neuromodulation Therapy (CNT) on Sympathetic Activity: An Acute Study
Measurement and recording of Muscle Sympathetic Neural Activity (MSNA) using microneurography, will be applied to subjects who have been already implanted with a Moderato IPG delivering the BackBeat CNT and/or pacing signals. Several tests will be performed by experienced professionals to ensure the acquired sympathetic nerve signals arise from the targeted nerve source.
The Moderato Programmer will be then used to program different sets of CNT for several minutes with a several minutes interval between delivery periods. This delivery pattern is used will allow to acquire sympathetic nerve signals with and without CNT. Subject blood pressure, respiration and ECG data will be collected and recorded, both for safety and for evaluation of CNT dependent secondary indicators of sympathetic activity.
Read the detailed description
This will be a multi-center , open-label, non-randomized acute pilot study. The Moderato System is approved for marketing in Europe (has a CE mark) for standard pacing and the treatment of high blood pressure in patients requiring standard cardiac pacing. The therapy delivered by the Moderato system is referred to as CNT (Cardiac Neuromodulation Therapy).
Measurement and recording of Muscle Sympathetic Neural Activity (MSNA) using microneurography, has been used extensively [see reference 4,5]. A small, thin metal needle is inserted through the skin near the knee in proximity to a major nerve that is close to the skin (a few millimeters depth). The electrical activity of the nerve measured by the needle is a direct indication of peripheral sympathetic activity.
This measurement technique will be applied to subjects who are already implanted with a Moderato IPG that can deliver the BackBeat CNT pacing signals, whether CNT pacing was activated or not.
In recumbent position (lying in a bed), insertion of a microneurography needle (FHC 35mm long, 0.2mm diameter Tungsten microelectrodes model UNP35F2U) to the correct recording position is attempted for no more than 1 hour. This has been successful in approximately 75% of patients in previous MSNA studies. An identical reference needle is inserted within 2 cm of the first electrode. The needles are connected to a recording system (ADInstruments PowerLab). Once sympathetic activity can be measured using the needles, a cold pressor test is performed. In this test, the subject's hand is placed in cold water for up to 2 minutes. This test is known to affect sympathetic activity and is used to calibrate the measurement and recording system.
The Moderato Programmer is then used to program the implanted Moderato IPG to deliver different sets of CNT pacing signals parameters, each for several minutes with a several minutes interval between delivery periods. This delivery pattern is used in order to measure the effect of CNT pacing signals delivery on sympathetic activity level both during and after CNT pacing signals delivery. Subject blood pressure, respiration and ECG data is also collected and recorded, both for safety reasons and to evaluate the effect of CNT on secondary indicators of sympathetic activity.
After the different CNT pacing signal sets are delivered, the microneurography needles will be removed, the patient disconnected from all other measurement devices, and the procedure concluded.
Patients will be considered as having completed the study at the conclusion of the acute procedure unless a safety event is observed during the acute procedure in which case the patients will be followed until the event has been resolved.
- Conditions
- Hypertension
- Being tested
- Experimental group
- Keywords
- Moderato implant
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupProcedure or surgery
In the setting phase subjects will be in recumbent position. A microneurography needle (0.2mm diameter isolated Tungsten micro-electrode) will be placed under the skin. An identical (not isolated) reference needle tip will be inserted within 2 cm of the first electrode. These are connected to a recording system (ADInstruments PowerLab). Once sympathetic activity can be measured using the needles, a sympathetic specific test will be used to calibrate the measurement and recording system. In the testing phase sequential pacing and CNT delivery will be programmed for a few minutes, the whole procedure expected to last less than 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All subjects enrolled will be in the same experimental group. Receives: Procedure: Experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic activity will be calculated as burst frequency (bursts/min) and as burst incidence (bursts/100 heartbeats). A change in the nerve activity occurring between pacing and CNT is expected.
Nerve firing is organised in burst activity which can be detected by the data acquisition system
Measured: through study completion (18 months)
Secondary outcomes (1)
A change in Systolic Blood Pressure
CNT main action is a reduction of the Systolic Blood Pressure
Measured: through study completion (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start10 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Indirect evidence \[see reference 1\] shows that CNT may decrease the level of sympathetic activity locally (in the heart) and systemically. However, this effect was never directly measured in an experiment. It is also theorized that the decrease of sympathetic activity may persist for some time after CNT delivery is stopped, but this has to be verified using direct sympathetic activity level measurement. Such direct evidence of sympathetic activity reduction may enable application of CNT therapy to other diseases and patients that do not have adequate therapies today, such as heart failure.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BackBeat Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bela Merkely, D, Ph.D., Principal investigator, Heart and vascular Centre, Semmelweiss University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462405
- Sponsor's protocol ID
- CS-09 BBM MSNA
- Status last verified
- May 2026
- First submitted
- 14 Jul 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heusser K, Tank J, Engeli S, Diedrich A, Menne J, Eckert S, Peters T, Sweep FC, Haller H, Pichlmaier AM, Luft FC, Jordan J. Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension. 2010 Mar;55(3):619-26. doi: 10.1161/HYPERTENSIONAHA.109.140665. Epub 2010 Jan 25.
PubMed 20101001Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011 Feb;17(2):167-78. doi: 10.1016/j.cardfail.2010.09.004. Epub 2010 Oct 29.
PubMed 21300307Hering D, Lambert EA, Marusic P, Walton AS, Krum H, Lambert GW, Esler MD, Schlaich MP. Substantial reduction in single sympathetic nerve firing after renal denervation in patients with resistant hypertension. Hypertension. 2013 Feb;61(2):457-64. doi: 10.1161/HYPERTENSIONAHA.111.00194. Epub 2012 Nov 19.
PubMed 23172929
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneurography MSNA Measurements for Evaluating the Effect of BackBeat Medical Cardiac Neuromodulation Therapy (CNT) on Sympathetic Activity: An Acute Study
- ClinicalTrials.gov ID
- NCT05462405
- Acronym / sponsor ID
- CS-09 BBM MSNA
- Conditions
- Hypertension
- Keywords
- Moderato implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- BackBeat Medical IncIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Jul 2022 (actual)
- 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.
Measurement and recording of Muscle Sympathetic Neural Activity (MSNA) using microneurography, will be applied to subjects who have been already implanted with a Moderato IPG delivering the BackBeat CNT and/or pacing signals. Several tests will be performed by experienced professionals to ensure the acquired sympathetic nerve signals arise from the targeted nerve source.
The Moderato Programmer will be then used to program different sets of CNT for several minutes with a several minutes interval between delivery periods. This delivery pattern is used will allow to acquire sympathetic nerve signals with and without CNT. Subject blood pressure, respiration and ECG data will be collected and recorded, both for safety and for evaluation of CNT dependent secondary indicators of sympathetic activity.
Detailed description
This will be a multi-center , open-label, non-randomized acute pilot study. The Moderato System is approved for marketing in Europe (has a CE mark) for standard pacing and the treatment of high blood pressure in patients requiring standard cardiac pacing. The therapy delivered by the Moderato system is referred to as CNT (Cardiac Neuromodulation Therapy).
Measurement and recording of Muscle Sympathetic Neural Activity (MSNA) using microneurography, has been used extensively [see reference 4,5]. A small, thin metal needle is inserted through the skin near the knee in proximity to a major nerve that is close to the skin (a few millimeters depth). The electrical activity of the nerve measured by the needle is a direct indication of peripheral sympathetic activity.
This measurement technique will be applied to subjects who are already implanted with a Moderato IPG that can deliver the BackBeat CNT pacing signals, whether CNT pacing was activated or not.
In recumbent position (lying in a bed), insertion of a microneurography needle (FHC 35mm long, 0.2mm diameter Tungsten microelectrodes model UNP35F2U) to the correct recording position is attempted for no more than 1 hour. This has been successful in approximately 75% of patients in previous MSNA studies. An identical reference needle is inserted within 2 cm of the first electrode. The needles are connected to a recording system (ADInstruments PowerLab). Once sympathetic activity can be measured using the needles, a cold pressor test is performed. In this test, the subject's hand is placed in cold water for up to 2 minutes. This test is known to affect sympathetic activity and is used to calibrate the measurement and recording system.
The Moderato Programmer is then used to program the implanted Moderato IPG to deliver different sets of CNT pacing signals parameters, each for several minutes with a several minutes interval between delivery periods. This delivery pattern is used in order to measure the effect of CNT pacing signals delivery on sympathetic activity level both during and after CNT pacing signals delivery. Subject blood pressure, respiration and ECG data is also collected and recorded, both for safety reasons and to evaluate the effect of CNT on secondary indicators of sympathetic activity.
After the different CNT pacing signal sets are delivered, the microneurography needles will be removed, the patient disconnected from all other measurement devices, and the procedure concluded.
Patients will be considered as having completed the study at the conclusion of the acute procedure unless a safety event is observed during the acute procedure in which case the patients will be followed until the event has been resolved.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Indirect evidence [see reference 1] shows that CNT may decrease the level of sympathetic activity locally (in the heart) and systemically. However, this effect was never directly measured in an experiment. It is also theorized that the decrease of sympathetic activity may persist for some time after CNT delivery is stopped, but this has to be verified using direct sympathetic activity level measurement. Such direct evidence of sympathetic activity reduction may enable application of CNT therapy to other diseases and patients that do not have adequate therapies today, such as heart failure.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Experimental groupAll subjects enrolled will be in the same experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is already implanted with a Moderato IPG that can be used to deliver CNT pacing signals, whether CNT pacing was activated or not.
- Subject is willing and able to comply with the study and procedures.
Key exclusion criteria (14 listed)
- Subject is dependent on 100% ventricular pacing.
- Subject has symptoms of heart failure, NYHA Class III or greater.
- Subject has an ejection fraction of 25% or less
- Subject's systolic blood pressure is less than 100 mm Hg on the day of recording.
- Subject has decompensated heart failure
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 |
|---|---|---|
| Experimental groupIn the setting phase subjects will be in recumbent position. A microneurography needle (0.2mm diameter isolated Tungsten micro-electrode) will be placed under the skin. An identical (not isolated) reference needle tip will be inserted within 2 cm of the first electrode. These are connected to a recording system (ADInstruments PowerLab). Once sympathetic activity can be measured using the needles, a sympathetic specific test will be used to calibrate the measurement and recording system. In the testing phase sequential pacing and CNT delivery will be programmed for a few minutes, the whole procedure expected to last less than 2 hours. | Procedure or surgery | Experimental group |
Primary outcome
Sympathetic activity will be calculated as burst frequency (bursts/min) and as burst incidence (bursts/100 heartbeats). A change in the nerve activity occurring between pacing and CNT is expected.
Time frame: through study completion (18 months)
Nerve firing is organised in burst activity which can be detected by the data acquisition system
1 secondary outcome
A change in Systolic Blood Pressure
Time frame: through study completion (18 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 20101001Heusser K, Tank J, Engeli S, Diedrich A, Menne J, Eckert S, Peters T, Sweep FC, Haller H, Pichlmaier AM, Luft FC, Jordan J. Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension. 2010 Mar;55(3):619-26. doi: 10.1161/HYPERTENSIONAHA.109.140665. Epub 2010 Jan 25.
- Results publication: PubMed 21300307Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011 Feb;17(2):167-78. doi: 10.1016/j.cardfail.2010.09.004. Epub 2010 Oct 29.
- Results publication: PubMed 23172929Hering D, Lambert EA, Marusic P, Walton AS, Krum H, Lambert GW, Esler MD, Schlaich MP. Substantial reduction in single sympathetic nerve firing after renal denervation in patients with resistant hypertension. Hypertension. 2013 Feb;61(2):457-64. doi: 10.1161/HYPERTENSIONAHA.111.00194. Epub 2012 Nov 19.
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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.
Bela Merkely, D, Ph.D. principal investigator
Heart and vascular Centre, Semmelweiss University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Hypertension, run by BackBeat Medical Inc at 1 site in Hungary.
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 2 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. 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 Hungary. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Sympathetic activity will be calculated as burst frequency (bursts/min) and as burst incidence (bursts/100 heartbeats). A change in the nerve activity occurring between pacing and CNT is expected. (time frame: through study completion (18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462405, which also lists 3 linked publications.
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 5 May 2026.