Hypertension,EssentialPhase 1/2NCT05086523
Cardiac Neuromodulation Therapy (CNT) "Washout" Sub-Study
A Phase 1/2 study testing Pacing (BackBeat Moderato) in people with Hypertension,Essential and Systolic Hypertension, run by BackBeat Medical Inc at 6 sites in 3 countries.
Trial summary
This washout protocol is structured as a sub-study for patients willing to participate after finishing the double blind randomised phase of the clinical trial, NCT02837445. Devices will be turned off for a week approximately. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension,Essential, Systolic Hypertension
- What is being tested?
- Pacing (BackBeat Moderato)
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 25 Oct 2021to 11 Aug 2023
- Phase
- Phase 1/2
- 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
- Subject is implanted with a Moderato® implantable pulse generator (IPG) and is being followed by the site per standard of care.
- Subject has an average office systolic blood pressure > 130 mmHg and < 170 mmHg at the sub-study screening visit.
Who cannot join
- Subject has permanent atrial fibrillation.
- Subject had significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats) in the past month. Atrial fibrillation/flutter burden will be determined by interrogation of the Moderato pulse generator.
- Subject experienced neurological events (stroke or TIA) within the past year. Subject have had a serious adverse event classified as related to CNT or the Backbeat Moderato device.
- Female subject who is pregnant, breast-feeding, intends to become pregnant or has the possibility of becoming pregnant during the conduct of the study and is not willing to use contraception during the study.
- Subject cannot or is unwilling to provide informed consent.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Poland4 sites
Szpital Kliniczny Przemiemienia Panskiego
Poznan, 61-848
Pomeranian Medical University Hospital no. 2
Szczecin, 70-111
Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
Warsaw, 02-097
Silesian Center for Heart Diseases
Zabrze, 41-800
About this study
Official title: Addendum to Protocol CS-03: Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial, NCT02837445
This washout protocol is structured as a sub-study for patients willing to participate after finishing the double blind randomised phase of the clinical trial, NCT02837445. Devices will be turned off for a week approximately. Patients will have their PHC programmed to automatically turn off 24 hr after a medical and technical visit and remain in regular pacing. Ambulatory recording of the BP will start at the end of the visit, and continue for 24 hr after the turn off time (48 hr recording). Conversely, patients will return at the end of the first week, when a second 48 hr recording will be initiated, this time, the PHC will be programmed to turn on 24 hr later. The recordings therefore will provide data of the ON to OFF transition for the evaluation of the residual effect of PHC after 24 h and after week.
Read the detailed description
As detailed in protocol CS-03, the BackBeat Moderato system applies standard pacing signals according to a specially timed, alternating sequence short and longer atrioventricular (AV) delays, to reduce blood pressure as a treatment for hypertension. The algorithm that governs the delivery of these pacing signals is referred to as Cardiac Neuromodulation Therapy (CNT) and the signals are referred to as Programable Hypertension Control (PHC) signals, (refer to Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial, NCT02837445) As currently used, CNT requires continuous right ventricle (RV) pacing. However, due to potentially long-term effects of CNT on baroceptor function, intermittent deactivation of CNT could reduce the overall amount of pacing without loss of efficacy. Support for this hypothesis comes from a preclinical testing of CNT that was detailed in "Chapter II - Pre-Clinical Testing" of the approved Investigator Brochure. BackBeat Medical conducted a chronic feasibility study in 4 dogs with hypertension induced by renal artery banding which were implanted with a Moderato IPG for 4 months. Results from this study showed that when CNT was turned off after 30 days of continuous CNT, there was a very slow increase in systolic pressure, approaching pre-therapy levels only several weeks later. A 50% residual effect remained at 20 days, with a total washout period of approximately 30 days.
One possible explanation for this observation is that the signal beneficially changes the pressure"set point" of the baroceptor reflexes. Changes in the set point could result from changes at the level of either the pressure sensor in the carotid sinus or within the pressure regulatory region of the central nervous system; namely the nucleus tractus solitarius (NTS) in the medulla oblongata.
This sub-study aims to evaluate whether and for how long the blood-pressure lowering effect of CNT persists following its cessation in patients who have been treated with CNT for a prolonged period of time.
- Conditions
- Hypertension,Essential, Systolic Hypertension
- Being tested
- Programmable Hypertension Control (BackBeat Moderato), Pacing (BackBeat Moderato)
- Medical subject headings
- Essential Hypertension, Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmable Hypertension Control (BackBeat Moderato)Device
Programmable Hypertension Control can be turned OFF without affecting regular pacing
Pacing (BackBeat Moderato)Device
Programmable Hypertension Control can be turned OFF without affecting regular pacing
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure (SBP) between baseline (PHC ON) and PHC OFF at two consecutive time points: (a) after one day and (b) after a week of PHC OFF
The first 24 hr of the first recording will be used to obtain the average for the baseline SBP value. As PHC is automatically turned OFF while the recording continues for another 24 hrs, the latter 24 hr will be used to obtain the average SBP of the first day with PHC OFF. A week later, the first 24 hr of the second recording will be used to obtain the average change in SBP to compare to the baseline (PHC ON).
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start25 Oct 2021
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
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 Hypertension,EssentialStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Subjects participating in this study, had been already agreed to participate in its preceding CS-03 study, NCT02909868. The study involves therefore patients whose endpoints had been reached, ended the mentioned study period and are on standard of care. The concept of the PHC washout encompasses the evaluation of how long the therapy remains viable after switching the device to normal pacemaker mode. Each patient serves as his/her own control, in the PHC ON (baseline) to OFF transition (early time point), then a week later again, the OFF value (late time point) will be compared to baseline.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- BackBeat Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086523
- Sponsor's protocol ID
- CNT Washout substudy
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.
PubMed 26699604Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7.
PubMed 32034481Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Bohm M; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170. doi: 10.1016/S0140-6736(17)32281-X. Epub 2017 Aug 28.
PubMed 28859944
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addendum to Protocol CS-03: Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial, NCT02837445
- ClinicalTrials.gov ID
- NCT05086523
- Acronym / sponsor ID
- CNT Washout substudy
- Conditions
- Hypertension,Essential, Systolic Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BackBeat Medical IncIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 21 Oct 2021 (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.
This washout protocol is structured as a sub-study for patients willing to participate after finishing the double blind randomised phase of the clinical trial, NCT02837445. Devices will be turned off for a week approximately. Patients will have their PHC programmed to automatically turn off 24 hr after a medical and technical visit and remain in regular pacing. Ambulatory recording of the BP will start at the end of the visit, and continue for 24 hr after the turn off time (48 hr recording). Conversely, patients will return at the end of the first week, when a second 48 hr recording will be initiated, this time, the PHC will be programmed to turn on 24 hr later. The recordings therefore will provide data of the ON to OFF transition for the evaluation of the residual effect of PHC after 24 h and after week.
Detailed description
As detailed in protocol CS-03, the BackBeat Moderato system applies standard pacing signals according to a specially timed, alternating sequence short and longer atrioventricular (AV) delays, to reduce blood pressure as a treatment for hypertension. The algorithm that governs the delivery of these pacing signals is referred to as Cardiac Neuromodulation Therapy (CNT) and the signals are referred to as Programable Hypertension Control (PHC) signals, (refer to Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial, NCT02837445) As currently used, CNT requires continuous right ventricle (RV) pacing. However, due to potentially long-term effects of CNT on baroceptor function, intermittent deactivation of CNT could reduce the overall amount of pacing without loss of efficacy. Support for this hypothesis comes from a preclinical testing of CNT that was detailed in "Chapter II - Pre-Clinical Testing" of the approved Investigator Brochure. BackBeat Medical conducted a chronic feasibility study in 4 dogs with hypertension induced by renal artery banding which were implanted with a Moderato IPG for 4 months. Results from this study showed that when CNT was turned off after 30 days of continuous CNT, there was a very slow increase in systolic pressure, approaching pre-therapy levels only several weeks later. A 50% residual effect remained at 20 days, with a total washout period of approximately 30 days.
One possible explanation for this observation is that the signal beneficially changes the pressure"set point" of the baroceptor reflexes. Changes in the set point could result from changes at the level of either the pressure sensor in the carotid sinus or within the pressure regulatory region of the central nervous system; namely the nucleus tractus solitarius (NTS) in the medulla oblongata.
This sub-study aims to evaluate whether and for how long the blood-pressure lowering effect of CNT persists following its cessation in patients who have been treated with CNT for a prolonged period of time.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Subjects participating in this study, had been already agreed to participate in its preceding CS-03 study, NCT02909868. The study involves therefore patients whose endpoints had been reached, ended the mentioned study period and are on standard of care. The concept of the PHC washout encompasses the evaluation of how long the therapy remains viable after switching the device to normal pacemaker mode. Each patient serves as his/her own control, in the PHC ON (baseline) to OFF transition (early time point), then a week later again, the OFF value (late time point) will be compared to baseline.
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 implanted with a Moderato® implantable pulse generator (IPG) and is being followed by the site per standard of care.
- Subject has an average office systolic blood pressure > 130 mmHg and < 170 mmHg at the sub-study screening visit.
Key exclusion criteria (5 listed)
- Subject has permanent atrial fibrillation.
- Subject had significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats) in the past month. Atrial fibrillation/flutter burden will be determined by interrogation of the Moderato pulse generator.
- Subject experienced neurological events (stroke or TIA) within the past year. Subject have had a serious adverse event classified as related to CNT or the Backbeat Moderato device.
- Female subject who is pregnant, breast-feeding, intends to become pregnant or has the possibility of becoming pregnant during the conduct of the study and is not willing to use contraception during the study.
- Subject cannot or is unwilling to provide informed consent.
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 |
|---|---|---|
| Programmable Hypertension Control (BackBeat Moderato)Programmable Hypertension Control can be turned OFF without affecting regular pacing | Device | – |
| Pacing (BackBeat Moderato)Programmable Hypertension Control can be turned OFF without affecting regular pacing | Device | – |
Primary outcome
Change in Systolic Blood Pressure (SBP) between baseline (PHC ON) and PHC OFF at two consecutive time points: (a) after one day and (b) after a week of PHC OFF
Time frame: one week
The first 24 hr of the first recording will be used to obtain the average for the baseline SBP value. As PHC is automatically turned OFF while the recording continues for another 24 hrs, the latter 24 hr will be used to obtain the average SBP of the first day with PHC OFF. A week later, the first 24 hr of the second recording will be used to obtain the average change in SBP to compare to the baseline (PHC ON).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 26699604Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.
- Background: PubMed 32034481Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7.
- Background: PubMed 28859944Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Bohm M; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170. doi: 10.1016/S0140-6736(17)32281-X. Epub 2017 Aug 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pacing (BackBeat Moderato) in people with Hypertension,Essential and Systolic Hypertension, run by BackBeat Medical Inc at 6 sites in 3 countries.
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 5 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: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, Czechia, 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Systolic Blood Pressure (SBP) between baseline (PHC ON) and PHC OFF at two consecutive time points: (a) after one day and (b) after a week of PHC OFF (time frame: one week). 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 NCT05086523, 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 22 Jun 2026.