HypertensionNCT01745172
Carotid Body Removal for the Treatment of Resistant Hypertension
A study testing Carotid body excision in people with Hypertension, run by Noblewell at 1 site in United Kingdom.
Trial summary
This is a pilot study to assess the effectiveness, safety and feasibility of carotid body removal in patients with high blood pressure (hypertension) resistant to medical treatment. Patients with high blood pressure are at significant risk of medical complications including stroke and heart disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Carotid body excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Jun 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of participants will be 18-75 years
- Resistant HTN criteria:
- Daytime mean ambulatory systolic blood pressure ≥135mmHg and office systolic blood pressure ≥150mmHg
- Patients on at least three anti-hypertensive medications, including a diuretic, at maximum tolerated dose
- No evidence of causes for secondary HTN following thorough clinical assessment
- Patient medication concordance will be monitored via medication/blood pressure diary
Who cannot join
- Calculated GFR <45ml/min/1.73m2
- Carotid body located outside the defined carotid septum
- Obstructive carotid atherosclerotic disease with >50% stenosis
- Oxygen desaturation at rest below 92%
- Known structural lung disease
- Requirement for oxygen therapy to maintain oxygen saturation
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- Patients wish to participate in mountain climbing, skin diving or free diving
- Pregnancy or anticipation of pregnancy
- Palliative care/chemotherapy
- Acute coronary syndrome or unstable angina
- Stroke or transient ischaemic attack (TIA) < 6 months prior to procedure
- Expected life expectancy less than 12 months due to other disease
- Intravenous drug use
- Alcohol intake >28 units/week
- Febrile illness within two weeks of participation
- Unable to attend for follow up appointments in Bristol at 1, 3, 6, 12 and 24 months post-operatively.
- MR imaging related exclusion criteria (all participants):
- Pace-maker, implantable cardiac defibrillator, cerebral metallic clips or other implanted metal devices/structures
- Unable to tolerate scanner or history of panic attacks/claustrophobia
- Learning disability, significant hearing or visual impairment (participant would need to able to communicate from within the MRI scanner)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research and Imaging Centre (CRIC) and the Bristol Heart Institute (BHI), University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8HW
About this study
Official title: Carotid Body Removal for the Treatment of Chronic Diseases Characterized by Excessive Central Sympathetic Activity Including Resistant Hypertension: a Pilot Study.
This is a pilot study to assess the effectiveness, safety and feasibility of carotid body removal in patients with high blood pressure (hypertension) resistant to medical treatment. Patients with high blood pressure are at significant risk of medical complications including stroke and heart disease. The principle research question is whether removal of the carotid body will lead to an improvement in the blood pressure of this patient group.
- Conditions
- Hypertension
- Being tested
- Carotid body excision
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid body excisionProcedure or surgery
This surgery does not involve any study drug or investigational device.
The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation.
| Study group | Role | What they receive |
|---|---|---|
| Carotid body excision | Experimental | Patients undergoing the carotid body excision to test the hypothesis that carotid body excision is sufficient to attain target blood pressure. Receives: Procedure: Carotid body excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Blood Pressure
Change from Baseline Blood Pressure at 3 months
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2016
- Study completionJun 2016
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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noblewell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul A. Sobotka, MD, Study director, Cibiem, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745172
- Sponsor's protocol ID
- CBR-BRISTOL.UK-CIBIEM
- Status last verified
- Oct 2016
- First submitted
- 22 Nov 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Body Removal for the Treatment of Chronic Diseases Characterized by Excessive Central Sympathetic Activity Including Resistant Hypertension: a Pilot Study.
- ClinicalTrials.gov ID
- NCT01745172
- Acronym / sponsor ID
- CBR-BRISTOL.UK-CIBIEM
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NoblewellIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Dec 2012 (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.
This is a pilot study to assess the effectiveness, safety and feasibility of carotid body removal in patients with high blood pressure (hypertension) resistant to medical treatment. Patients with high blood pressure are at significant risk of medical complications including stroke and heart disease. The principle research question is whether removal of the carotid body will lead to an improvement in the blood pressure of this patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid body excision | Experimental | Procedure: Carotid body excisionPatients undergoing the carotid body excision to test the hypothesis that carotid body excision is sufficient to attain target blood pressure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of participants will be 18-75 years
- Resistant HTN criteria:
Key exclusion criteria (20 listed)
- Calculated GFR <45ml/min/1.73m2
- Carotid body located outside the defined carotid septum
- Obstructive carotid atherosclerotic disease with >50% stenosis
- Oxygen desaturation at rest below 92%
- Known structural lung disease
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 |
|---|---|---|
| Carotid body excisionThis surgery does not involve any study drug or investigational device. The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation. | Procedure or surgery | Carotid body excision |
Primary outcome
Change of Blood Pressure
Time frame: Baseline and 3 months
Change from Baseline Blood Pressure at 3 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 18 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
Paul A. Sobotka, MD study director
Cibiem, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid body excision in people with Hypertension, run by Noblewell 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 20 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 18 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 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 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 of Blood Pressure (time frame: Baseline and 3 months). 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 18 Oct 2016.