Baroreflex Failure SyndromeUK-BATNCT03730519
UK Registry for Baroreflex Activation Therapy
A study testing Baroreflex Activation Therapy with Barostim Neo in people with Baroreflex Failure Syndrome and Hypertension, Resistant to Conventional Therapy, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
This study is a post-marketing open label single arm, single centre clinical trial of electrical carotid sinus stimulation with the Barostim Neo device to target sub-optimally controlled arterial hypertension or highly variable blood pressure in patients for whom no alternative therapies are available. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Baroreflex Failure Syndrome, Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Baroreflex Activation Therapy with Barostim Neo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2018to 1 Nov 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol restrictions.
- The study subjects will be either:
- Refractory hypertensive patients (daytime systolic ambulatory BP (ABP) > 150 mmHg) in whom all pharmacological approaches to control BP have failed or were intolerable.
- or II. Symptomatic patients with exaggerated BPV documented on daytime ABP monitoring (SD >18 mmHg) who cannot achieve effective BP control with pharmacological approaches
- For BPV group, evidence of peripheral baroreflex dysfunction as determined by non-invasive autonomic function testing
- Patients will have been established on a stable antihypertensive treatment regime for at least 1 month by the time of participation in the study and changes in pharmacological intervention for the duration of the trial are to be avoided unless clinically mandated.
Who cannot join
- HTN secondary to an identifiable and treatable cause
- Carotid atherosclerosis determined by ultrasound or angiographic evaluation greater than 50% stenosis
- Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
- Bifurcation of the carotid on the side planned needs to be below level of mandible by ultrasound
- Uncontrolled, symptomatic cardiac bradyarrhythmias.
- Myocardial infarction, unstable angina or cerebral vascular accident within 3 months before implant.
Show all 15Show fewer
- Clinically significant cardiac valvular disease
- Prior implant in the carotid sinus region,
- Currently implanted electrical medical devices,
- End stage renal (with eGFR <15 mL/min) or liver disease
- Pregnancy or contemplating pregnancy.
- BMI > 40 kg/sq m
- Inability to tolerate ambulatory blood pressure monitoring
- Patient with other co-morbidity likely to have life expectancy <3y
- Systolic left heart failure with ejection fraction <40%
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
William Harvey Research Institute
London, EC1M 6BQ
About this study
Official title: Investigation of the Efficacy and Safety of Baroreflex Activation Therapy in Patients With Refractory Hypertension and Those With Highly Variable Blood Pressure Due to Peripheral Baroreflex Failure
This study is a post-marketing open label single arm, single centre clinical trial of electrical carotid sinus stimulation with the Barostim Neo device to target sub-optimally controlled arterial hypertension or highly variable blood pressure in patients for whom no alternative therapies are available.
Read the detailed description
Hypertension is a major health issue globally and is the number one risk factor for cardiovascular morbidity and mortality. Despite decades of innovation in pharmacotherapeutics, suboptimal BP control remains a problem worldwide. Alternative therapies for hypertension are therefore urgently needed.
This project addresses the following important unmet needs:
- . Refractory hypertension may respond to device based approaches such as baroreflex activation therapy (BAT) but further independent research is needed to clarify the role of novel technologies. It is not possible to undertake research into BAT at all due to lack of funding and the manufacturer is not undertaking clinical trials of the therapy in the UK.
- . Patients with highly variable BP disorders constitute a very small but important sub-group of the hypertensive population but are the most challenging to manage as no drug therapy exists to combat high and low BP simultaneously. This group of patients have very poor quality of life and are unable to work due to their profound BP variability. Many of them experience frequent hospital admissions for lengthy periods as a result of potentially life-threatening hypertension. Treatment with BAT may feasibly improve management of their condition by dampening BP variability and preventing hypertensive surges whilst allowing the patients to continue with measures to prevent hypotension using compression hosiery and drugs.
This project has the following objectives
Primary:
To establish a UK national registry for treatment of blood pressure disorders with baroreflex activation therapy in the following patient groups:
- Patients with refractory hypertension (Ref-HTN) regardless of pharmacotherapy (up to 15 patients)
- Patients with highly variable BP disorders (BPV) the aetiology of which indicates that peripheral baroreflex failure is the underlying diagnosis (up to 10 patients)
Secondary
- To undertake mechanistic research to better understand the mechanism of action of baroreflex activation therapy and the role of the baroreflex in hypertensive disorders by measuring indices of autonomic function (parasympathetic and sympathetic nervous system tone) and humoral factors such as renin/aldosterone and copeptin in response to BAT.
- To position the Barts BP Clinic as a national referral centre for the management of complex circulatory disorders with access to experimental treatments unavailable elsewhere in the UK.
- To foster a more 'joined up' approach to BAT by promoting awareness of its benefits among primary care practitioners and other secondary care specialists.
- Being tested
- Baroreflex Activation Therapy with Barostim Neo
- Keywords
- Refractory Hypertension
- Medical subject headings
- Hypertension Resistant to Conventional Therapy, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baroreflex Activation Therapy with Barostim NeoDevice
Also called Electrical Carotid sinus stimulation
Baroreflex activation therapy (BAT) delivers electrical field stimulation at the carotid sinus to lower BP.
| Study group | Role | What they receive |
|---|---|---|
| Patients with refractory hypertension | Active comparator | Patients with refractory hypertension which cannot be controlled with drug therapy in the hands of hypertension specialists will be treated with Baroreflex Activation Therapy with Barostim Neo and followed up for a period of up to 3 years Receives: Device: Baroreflex Activation Therapy with Barostim Neo |
| Patients with highly variable BP | Active comparator | Patients with symptomatic highly variable blood pressure due to afferent baroreceptor failure which cannot be controlled with drug therapy in the hands of hypertension specialists will be treated with Baroreflex Activation Therapy with Barostim Neo and followed up for a period of up to 3 years Receives: Device: Baroreflex Activation Therapy with Barostim Neo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Systolic & Diastolic Blood Pressure changes in patients with uncontrolled (refractory) hypertension
Measured: 6 months
Ambulatory Systolic & Diastolic Blood Pressure variability change in patients with highly variable BP due to baroreflex failure
Measured: 6 months
Incidence of Treatment-Emergent Adverse Events in both groups of patients
Measured: 6 months
Secondary outcomes (2)
Change in European Quality of Life 5 dimension (Eq-5D) score in both groups of patients
Eq5D is a standardised/validated instrument to assess health outcome. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5D index of 1.0 indicates full health, and -0.59 denoted death
Measured: 6 months
Changes in autonomic indices in both groups of patients
Non-invasive measurement of parasympathetic (vagal) tone and sympathetic tone using a Neuroscope measurement device with real time beat to beat BP measurement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Nov 2018
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Why it stopped: Due to the pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baroreflex Failure SyndromeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a post-marketing open label twin arm, single centre clinical trial of electrical carotid sinus stimulation with the Barostim Neo device to target sub-optimally controlled arterial hypertension or highly variable blood pressure in patients for whom no alternative therapies are available.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- CVRx, Inc.
- Responsible party
- Principal investigator, Melvin D Lobo, Queen Mary University of London
- Investigators
- Melvin D Lobo, MBChB PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730519
- Sponsor's protocol ID
- MCPG1M8R
- Acronym
- UK-BAT
- Status last verified
- Jun 2023
- First submitted
- 16 Oct 2018
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy and Safety of Baroreflex Activation Therapy in Patients With Refractory Hypertension and Those With Highly Variable Blood Pressure Due to Peripheral Baroreflex Failure
- ClinicalTrials.gov ID
- NCT03730519
- Acronym / sponsor ID
- UK-BAT / MCPG1M8R
- Keywords
- Refractory Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the pandemic
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- CVRx, Inc.
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 5 Nov 2018 (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 study is a post-marketing open label single arm, single centre clinical trial of electrical carotid sinus stimulation with the Barostim Neo device to target sub-optimally controlled arterial hypertension or highly variable blood pressure in patients for whom no alternative therapies are available.
Detailed description
Hypertension is a major health issue globally and is the number one risk factor for cardiovascular morbidity and mortality. Despite decades of innovation in pharmacotherapeutics, suboptimal BP control remains a problem worldwide. Alternative therapies for hypertension are therefore urgently needed.
This project addresses the following important unmet needs:
- . Refractory hypertension may respond to device based approaches such as baroreflex activation therapy (BAT) but further independent research is needed to clarify the role of novel technologies. It is not possible to undertake research into BAT at all due to lack of funding and the manufacturer is not undertaking clinical trials of the therapy in the UK.
- . Patients with highly variable BP disorders constitute a very small but important sub-group of the hypertensive population but are the most challenging to manage as no drug therapy exists to combat high and low BP simultaneously. This group of patients have very poor quality of life and are unable to work due to their profound BP variability. Many of them experience frequent hospital admissions for lengthy periods as a result of potentially life-threatening hypertension. Treatment with BAT may feasibly improve management of their condition by dampening BP variability and preventing hypertensive surges whilst allowing the patients to continue with measures to prevent hypotension using compression hosiery and drugs.
This project has the following objectives
Primary:
To establish a UK national registry for treatment of blood pressure disorders with baroreflex activation therapy in the following patient groups:
- Patients with refractory hypertension (Ref-HTN) regardless of pharmacotherapy (up to 15 patients)
- Patients with highly variable BP disorders (BPV) the aetiology of which indicates that peripheral baroreflex failure is the underlying diagnosis (up to 10 patients)
Secondary
- To undertake mechanistic research to better understand the mechanism of action of baroreflex activation therapy and the role of the baroreflex in hypertensive disorders by measuring indices of autonomic function (parasympathetic and sympathetic nervous system tone) and humoral factors such as renin/aldosterone and copeptin in response to BAT.
- To position the Barts BP Clinic as a national referral centre for the management of complex circulatory disorders with access to experimental treatments unavailable elsewhere in the UK.
- To foster a more 'joined up' approach to BAT by promoting awareness of its benefits among primary care practitioners and other secondary care specialists.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a post-marketing open label twin arm, single centre clinical trial of electrical carotid sinus stimulation with the Barostim Neo device to target sub-optimally controlled arterial hypertension or highly variable blood pressure in patients for whom no alternative therapies are available.
| Arm | Type | Receives |
|---|---|---|
| Patients with refractory hypertension | Active comparator | Device: Baroreflex Activation Therapy with Barostim NeoPatients with refractory hypertension which cannot be controlled with drug therapy in the hands of hypertension specialists will be treated with Baroreflex Activation Therapy with Barostim Neo and followed up for a period of up to 3 years |
| Patients with highly variable BP | Active comparator | Device: Baroreflex Activation Therapy with Barostim NeoPatients with symptomatic highly variable blood pressure due to afferent baroreceptor failure which cannot be controlled with drug therapy in the hands of hypertension specialists will be treated with Baroreflex Activation Therapy with Barostim Neo and followed up for a period of up to 3 years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol restrictions.
- The study subjects will be either:
- or II. Symptomatic patients with exaggerated BPV documented on daytime ABP monitoring (SD >18 mmHg) who cannot achieve effective BP control with pharmacological approaches
- For BPV group, evidence of peripheral baroreflex dysfunction as determined by non-invasive autonomic function testing
- Patients will have been established on a stable antihypertensive treatment regime for at least 1 month by the time of participation in the study and changes in pharmacological intervention for the duration of the trial are to be avoided unless clinically mandated.
Key exclusion criteria (15 listed)
- HTN secondary to an identifiable and treatable cause
- Carotid atherosclerosis determined by ultrasound or angiographic evaluation greater than 50% stenosis
- Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
- Bifurcation of the carotid on the side planned needs to be below level of mandible by ultrasound
- Uncontrolled, symptomatic cardiac bradyarrhythmias.
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 |
|---|---|---|
| Baroreflex Activation Therapy with Barostim NeoAlso: Electrical Carotid sinus stimulationBaroreflex activation therapy (BAT) delivers electrical field stimulation at the carotid sinus to lower BP. | Device | Patients with highly variable BP, Patients with refractory hypertension |
Primary outcome
Ambulatory Systolic & Diastolic Blood Pressure changes in patients with uncontrolled (refractory) hypertension
Time frame: 6 months
Ambulatory Systolic & Diastolic Blood Pressure variability change in patients with highly variable BP due to baroreflex failure
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events in both groups of patients
Time frame: 6 months
2 secondary outcomes
Change in European Quality of Life 5 dimension (Eq-5D) score in both groups of patients
Time frame: 6 months
Changes in autonomic indices in both groups of patients
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Due to the pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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.
Melvin D Lobo, MBChB PhD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baroreflex Activation Therapy with Barostim Neo in people with Baroreflex Failure Syndrome and Hypertension, Resistant to Conventional Therapy, run by Queen Mary University of London at 1 site in United Kingdom.
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 15 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 8 Jun 2023. 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 United Kingdom. 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?
The study was stopped early (reason given: Due to the pandemic). 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?
Ambulatory Systolic & Diastolic Blood Pressure changes in patients with uncontrolled (refractory) hypertension (time frame: 6 months). The study lists 3 primary outcomes in all. 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 8 Jun 2023.