Resistant HypertensionBATNCT02572024
The Effect of BATon BP and Sympathetic Function in Resistant Hypertension (The Nordic BAT Study)
A study testing BAT in people with Resistant Hypertension, run by Helsinki University Central Hospital at 5 sites in 4 countries.
Trial summary
Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These patients are at a clearly increased risk for end organ damage and mortality. Furthermore, arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary, metabolic, and sympathetic factors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- BAT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Nov 2015to Mar 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients have a daytime systolic ambulatory blood pressure 145 mmHg or more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs preferably including a diuretic), with no changes in medication for a minimum of 4 weeks prior to enrolment.
Who cannot join
- Patients with secondary causes of hypertension will be excluded.
- Further exclusion criteria are renal insufficiency with an estimated glomerular filtration rate ≤30 ml/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology [CKD-EPI] formula), untreated sleep apnoea, pregnancy, type 1 diabetes, alcohol or substance abuse or psychiatric illnesses, other heart rhythm than sinus (well controlled atrial fibrillation is not a contraindication), uncontrolled systolic heart failure (or an ejection fraction of less than 40% in echocardiography), aortic stenosis (mean gradient more than 25 mmHg in echocardiography).
- Myocardial infarction, hypertensive crisis, symptomatic orthostatic hypotension, unstable angina, syncope, or cerebral vascular accident within the 3 months before enrolment will also be exclusion criteria.
- Furthermore, known or suspected baroreflex failure or autonomic neuropathy, carotid artery stenosis as well as prior surgery, radiation, or endovascular stent placement in the carotid sinus region on both sides, as well as any complication that is a risk to the planned surgery are exclusion criteria.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Sweden2 sites
Sahlgrenska University Hospital, Sweden
Gothenburg
Skåne University Hospital
Malmö
About this study
Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These patients are at a clearly increased risk for end organ damage and mortality. Furthermore, arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary, metabolic, and sympathetic factors. However, the current treatment modalities have not been optimal in targeting the compensatory changes in sympathetic nervous system function and new strategies have been warranted.
Baroreflex activation therapy (BAT) is a special treatment option for some patients with RH that modulates the autonomic nervous system to restore sympathovagal balance. Notably, in BAT both long-term safety and efficacy in a large-scale, randomized, double blind, controlled trial has been shown. However, the trial design and BAT methodology resulted in that the first generation Rheos® system did not achieve the prespecified endpoints for short-term safety and efficacy.
Read more
Notably, a second-generation minimally invasive BAT system (Barostim Neo®) has now been developed to address these limitations although randomized, double blind, controlled clinical trials are still lacking. Noteworthy, in the recent European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines for the management of arterial hypertension, carotid baroreceptor stimulation is mentioned as one of the options to treat resistant hypertension.
Based on these data the aim of this randomized, double-blind, parallel-design clinical trial is to examine the effect of BAT compared to continuous pharmacotherapy on blood pressure, as well as arterial and cardiac function and structure using non-invasive high technology methodology, in a Nordic multicentre study.
This study will include 100 patients with RH (20 from Helsinki). Eligible patients are between 18 and 70 years and have a daytime systolic ambulatory blood pressure 145 mmHg or more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs preferably including a diuretic), with no changes in medication for a minimum of 4 weeks prior to enrolment. Patients with severe renal insufficiency, type 1 diabetes, psychiatric illness, severe cardiovascular disease, or any complication that is a risk to the planned surgery are exclusion criteria.
The primary end point is to test whether BAT reduces 24-hour systolic ambulatory blood pressure at 8 months of follow-up compared to continuous pharmacotherapy. Secondary end points are to test whether BAT reduces home blood pressure during follow-up compared to continuous pharmacotherapy, whether BAT reduces office blood pressure during follow-up compared to continuous pharmacotherapy, and the effect of BAT on autonomic function measured as eg. baroreflex sensitivity and heart rate variability.
- Conditions
- Resistant Hypertension
- Being tested
- BAT, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BATDevice
Baroreflex activation therapy device ON
PlaceboOther
Baroreflex activation therapy device OFF
| Study group | Role | What they receive |
|---|---|---|
| Baroreflex activation therapy | Active comparator | BAT ON Receives: Device: BAT |
| Placebo | Placebo comparator | BAT OFF Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic ambulatory blood pressure in response to BAT therapy
Unit: mmHg
Measured: 8 months
Secondary outcomes (3)
Change in systolic ambulatory blood pressure in response to BAT therapy
Unit: mmHg
Measured: 19 months
Change in home/office blood pressure in response to BAT therapy
Unit: mmHg
Measured: 19 months
Change in autonomic function in response to BAT therapy
Unit: ms/mmHg
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2022
- Study completionMar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resistant 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, University of Oslo, University of Helsinki, Sahlgrenska University Hospital, Skane University Hospital
- Responsible party
- Principal investigator, Daniel Gordin, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572024
- Sponsor's protocol ID
- BATstudy
- Acronym
- BAT
- Status last verified
- Mar 2022
- First submitted
- 7 Oct 2015
- Last updated
- 2 Mar 2023
- Results posted
- No
Publications
Simonsen JR, Vikatmaa L, Vikatmaa P, Laine M, Granroth-Wilding H, Groop PH, Tikkanen I, Gordin D. Sham-Controlled Randomized Pilot Trial on Baroreflex Activation Therapy in Resistant Hypertension. Hypertension. 2024 Aug;81(8):e91-e93. doi: 10.1161/HYPERTENSIONAHA.124.23088. Epub 2024 Jul 17. No abstract available.
PubMed 39018380
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BATon BP and Sympathetic Function in Resistant Hypertension (The Nordic BAT Study)
- ClinicalTrials.gov ID
- NCT02572024
- Acronym / sponsor ID
- BAT / BATstudy
- Conditions
- Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital, University of Oslo, University of Helsinki, Sahlgrenska University Hospital, Skane University Hospital
- Study start
- Nov 2015
- Primary completion
- Nov 2022 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 8 Oct 2015 (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.
Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These patients are at a clearly increased risk for end organ damage and mortality. Furthermore, arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary, metabolic, and sympathetic factors. However, the current treatment modalities have not been optimal in targeting the compensatory changes in sympathetic nervous system function and new strategies have been warranted.
Baroreflex activation therapy (BAT) is a special treatment option for some patients with RH that modulates the autonomic nervous system to restore sympathovagal balance. Notably, in BAT both long-term safety and efficacy in a large-scale, randomized, double blind, controlled trial has been shown. However, the trial design and BAT methodology resulted in that the first generation Rheos® system did not achieve the prespecified endpoints for short-term safety and efficacy.
Notably, a second-generation minimally invasive BAT system (Barostim Neo®) has now been developed to address these limitations although randomized, double blind, controlled clinical trials are still lacking. Noteworthy, in the recent European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines for the management of arterial hypertension, carotid baroreceptor stimulation is mentioned as one of the options to treat resistant hypertension.
Based on these data the aim of this randomized, double-blind, parallel-design clinical trial is to examine the effect of BAT compared to continuous pharmacotherapy on blood pressure, as well as arterial and cardiac function and structure using non-invasive high technology methodology, in a Nordic multicentre study.
This study will include 100 patients with RH (20 from Helsinki). Eligible patients are between 18 and 70 years and have a daytime systolic ambulatory blood pressure 145 mmHg or more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs preferably including a diuretic), with no changes in medication for a minimum of 4 weeks prior to enrolment. Patients with severe renal insufficiency, type 1 diabetes, psychiatric illness, severe cardiovascular disease, or any complication that is a risk to the planned surgery are exclusion criteria.
The primary end point is to test whether BAT reduces 24-hour systolic ambulatory blood pressure at 8 months of follow-up compared to continuous pharmacotherapy. Secondary end points are to test whether BAT reduces home blood pressure during follow-up compared to continuous pharmacotherapy, whether BAT reduces office blood pressure during follow-up compared to continuous pharmacotherapy, and the effect of BAT on autonomic function measured as eg. baroreflex sensitivity and heart rate variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baroreflex activation therapy | Active comparator | Device: BATBAT ON |
| Placebo | Placebo comparator | Other: PlaceboBAT OFF |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients have a daytime systolic ambulatory blood pressure 145 mmHg or more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs preferably including a diuretic), with no changes in medication for a minimum of 4 weeks prior to enrolment.
Key exclusion criteria (4 listed)
- Patients with secondary causes of hypertension will be excluded.
- Further exclusion criteria are renal insufficiency with an estimated glomerular filtration rate ≤30 ml/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology [CKD-EPI] formula), untreated sleep apnoea, pregnancy, type 1 diabetes, alcohol or substance abuse or psychiatric illnesses, other heart rhythm than sinus (well controlled atrial fibrillation is not a contraindication), uncontrolled systolic heart failure (or an ejection fraction of less than 40% in echocardiography), aortic stenosis (mean gradient more than 25 mmHg in echocardiography).
- Myocardial infarction, hypertensive crisis, symptomatic orthostatic hypotension, unstable angina, syncope, or cerebral vascular accident within the 3 months before enrolment will also be exclusion criteria.
- Furthermore, known or suspected baroreflex failure or autonomic neuropathy, carotid artery stenosis as well as prior surgery, radiation, or endovascular stent placement in the carotid sinus region on both sides, as well as any complication that is a risk to the planned surgery are exclusion criteria.
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 |
|---|---|---|
| BATBaroreflex activation therapy device ON | Device | Baroreflex activation therapy |
| PlaceboBaroreflex activation therapy device OFF | Other | Placebo |
Primary outcome
Change in systolic ambulatory blood pressure in response to BAT therapy
Time frame: 8 months
Unit: mmHg
3 secondary outcomes
Change in systolic ambulatory blood pressure in response to BAT therapy
Time frame: 19 months
Change in home/office blood pressure in response to BAT therapy
Time frame: 19 months
Change in autonomic function in response to BAT therapy
Time frame: 19 months
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 2 Mar 2023.
- Derived from this study: PubMed 39018380Simonsen JR, Vikatmaa L, Vikatmaa P, Laine M, Granroth-Wilding H, Groop PH, Tikkanen I, Gordin D. Sham-Controlled Randomized Pilot Trial on Baroreflex Activation Therapy in Resistant Hypertension. Hypertension. 2024 Aug;81(8):e91-e93. doi: 10.1161/HYPERTENSIONAHA.124.23088. Epub 2024 Jul 17. No abstract available.
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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.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAT in people with Resistant Hypertension, run by Helsinki University Central Hospital at 5 sites in 4 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 1 inclusion and 4 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, Denmark, Finland, Norway. 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.
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 ambulatory blood pressure in response to BAT therapy (time frame: 8 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 NCT02572024, which also lists 1 linked publication.
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 2 Mar 2023.