HypertensionDEBuT-HTNCT00710190
Device Based Therapy in Hypertension Trial
A study testing Rheos Baroreflex Hypertension Therapy System in people with Hypertension, run by CVRx, Inc. at 9 sites in 6 countries.
Trial summary
The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Rheos Baroreflex Hypertension Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Jul 2003to Oct 2011
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 21 years of age.
- Have been assessed to have bilateral carotid bifurcations located at or below C3 - C4.
- Have blood pressure greater than or equal to 160 mmHg systolic and/or greater than or equal to 90 mmHg diastolic despite at least two months of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
- Must be certified by the investigator as compliant to taking full doses of medications.
- Have signed an approved informed consent form for participation in this study.
Who cannot join
- Have been diagnosed with:
- Baroreflex failure or significant orthostatic hypotension
- Cardiac brady arrhythmias or chronic atrial fibrillation
- Have carotid atherosclerosis determined by ultrasound or angiographic evaluation with a stenosis of greater than 50%.
- Have prior surgery or radiation in either carotid sinus region
- Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
Show all 13Show fewer
- Are pregnant or contemplating pregnancy during the 4-month follow-up period.
- Are on dialysis
- Have hypertension secondary to a treatable cause
- Have clinically significant cardiac valvular disease
- Are unable to comply with protocol requirements.
- Are unlikely to survive the protocol follow-up period
- Are enrolled in another concurrent clinical trial
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Germany4 sites
University Hospital Bad Oeynhausen
Bad Oeynhausen
Charité Campus Buch
Berlin
Uniklinik Essen
Essen
University Hospital Hannover
Hanover
About this study
Official title: A Study of Baroreflex Hypertension Therapy in Refractory Hypertension
The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.
Read the detailed description
The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension Therapy(TM) in patients with refractory hypertension despite full pharmacologic therapy. Enrolled patients will be carefully assessed prior to receiving a permanently implanted Rheos System. Once the system is implanted, these patients will be followed closely for 1 month to establish baseline information. The Rheos System will be programmed "ON" at the 1 month follow-up and incrementally increased at 2 and 3-month follow-up evaluations. An assessment of safety and efficacy will be made at the 4-month follow-up. Enrolled patients will be followed annually thereafter.
- Conditions
- Hypertension
- Being tested
- Rheos Baroreflex Hypertension Therapy System
- Keywords
- Drug Resistant Hypertension, Refractory Hypertension, High Blood Pressure, Baroreflex Hypertension Therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheos Baroreflex Hypertension Therapy SystemDevice
This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Rheos Implant | Experimental | Not described Receives: Device: Rheos Baroreflex Hypertension Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the safety of Rheos(TM) Baroreflex Hypertension Therapy (TM) System by evaluating all adverse events and estimating the system and procedure related adverse event rate.
Measured: 4 months post implant
Demonstrate a 10 mmHg decrease from baseline (1-Month office cuff blood pressure) in systolic blood pressure after three months of incrementally optimized therapy.
Measured: 4 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJul 2003
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Baal, PhD, Study director, CVRx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710190
- Sponsor's protocol ID
- 360004-001
- Acronym
- DEBuT-HT
- Status last verified
- Oct 2016
- First submitted
- 1 Jul 2008
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Baroreflex Hypertension Therapy in Refractory Hypertension
- ClinicalTrials.gov ID
- NCT00710190
- Acronym / sponsor ID
- DEBuT-HT / 360004-001
- Conditions
- Hypertension
- Keywords
- Drug Resistant Hypertension, Refractory Hypertension, High Blood Pressure, Baroreflex Hypertension Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Jul 2008 (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 purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.
Detailed description
The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension Therapy(TM) in patients with refractory hypertension despite full pharmacologic therapy. Enrolled patients will be carefully assessed prior to receiving a permanently implanted Rheos System. Once the system is implanted, these patients will be followed closely for 1 month to establish baseline information. The Rheos System will be programmed "ON" at the 1 month follow-up and incrementally increased at 2 and 3-month follow-up evaluations. An assessment of safety and efficacy will be made at the 4-month follow-up. Enrolled patients will be followed annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheos Implant | Experimental | Device: Rheos Baroreflex Hypertension Therapy System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 21 years of age.
- Have been assessed to have bilateral carotid bifurcations located at or below C3 - C4.
- Have blood pressure greater than or equal to 160 mmHg systolic and/or greater than or equal to 90 mmHg diastolic despite at least two months of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
- Must be certified by the investigator as compliant to taking full doses of medications.
- Have signed an approved informed consent form for participation in this study.
Key exclusion criteria (13 listed)
- Have been diagnosed with:
- Have carotid atherosclerosis determined by ultrasound or angiographic evaluation with a stenosis of greater than 50%.
- Have prior surgery or radiation in either carotid sinus region
- Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
- Are pregnant or contemplating pregnancy during the 4-month follow-up period.
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 |
|---|---|---|
| Rheos Baroreflex Hypertension Therapy SystemThis therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure. | Device | Rheos Implant |
Primary outcome
Demonstrate the safety of Rheos(TM) Baroreflex Hypertension Therapy (TM) System by evaluating all adverse events and estimating the system and procedure related adverse event rate.
Time frame: 4 months post implant
Demonstrate a 10 mmHg decrease from baseline (1-Month office cuff blood pressure) in systolic blood pressure after three months of incrementally optimized therapy.
Time frame: 4 months post implant
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 21 Oct 2016.
- Related InfoLink provided by the sponsor.
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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.
Thomas Baal, PhD study director
CVRx, Inc.
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rheos Baroreflex Hypertension Therapy System in people with Hypertension, run by CVRx, Inc. at 9 sites in 6 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 5 inclusion and 13 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Czechia, Latvia, Netherlands, Poland and 1 more country. 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 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?
Demonstrate the safety of Rheos(TM) Baroreflex Hypertension Therapy (TM) System by evaluating all adverse events and estimating the system and procedure related adverse event rate. (time frame: 4 months post implant). The study lists 2 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 21 Oct 2016; AzTrials last refreshed its copy on 27 Oct 2026.