HypertensionNCT01729988
Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study
A study testing Carotid body excision in people with Hypertension, run by Noblewell at 1 site in Poland.
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
- 11 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2012to Jan 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
- Resistant HTN criteria with either confirmed sleep disordered breathing. Definition of HTN:Office SBP ≥ 160 mmHg and daytime mean ABPM ≥ 140 mm Hg
- Definition of sleep disordered breathing: SDB defined as mild to moderate obstructive, central or mixed sleep apnea defined as 5 < AHI < 30 with O2 desaturation not exceeding 80% during the night.
Who cannot join
- Calculated GFR < 30
- Carotid body located outside the defined carotid septum
- Obstructive carotid atherosclerotic disease
- Oxygen desaturation at rest below 92%
- Known structural lung disease (medical interview)
- 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 < 6 months prior to procedure
- Use of exogenous insulin AND history of hypoglycemic unawareness
- Stroke or transient ischaemic attack (TIA), or myocardial infarction < 6 months prior to procedure
- Expected life expectancy less that 24months due to other disease
- Intravenous drug use
- Excessive use of alcohol or sedatives (Alcohol intake >28 units/week)
- Obesity (BMI > 40)
- Upper airway or facial abnormalities
- Large neck circumference (>43.2 cm men; >40.6 cm women)
- Febrile illness within two weeks of participation
- Unable to attend for follow up appointments at 1, 3 and 6 months post operatively.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Hypertension and Diabetology, Medical University of Gdansk
Gdansk, 80-952
About this 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: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2016
- Study completionJan 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noblewell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul A. Sobotka, M.D., Study director, Cibiem, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729988
- Sponsor's protocol ID
- CBR-GDAPL-CIBIEM
- Status last verified
- Oct 2016
- First submitted
- 8 Nov 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- 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 Resistant Hypertension: a Pilot Study
- ClinicalTrials.gov ID
- NCT01729988
- Acronym / sponsor ID
- CBR-GDAPL-CIBIEM
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- NoblewellIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Nov 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 (2 listed)
- Resistant HTN criteria with either confirmed sleep disordered breathing. Definition of HTN:Office SBP ≥ 160 mmHg and daytime mean ABPM ≥ 140 mm Hg
- Definition of sleep disordered breathing: SDB defined as mild to moderate obstructive, central or mixed sleep apnea defined as 5 < AHI < 30 with O2 desaturation not exceeding 80% during the night.
Key exclusion criteria (20 listed)
- Calculated GFR < 30
- Carotid body located outside the defined carotid septum
- Obstructive carotid atherosclerotic disease
- Oxygen desaturation at rest below 92%
- Known structural lung disease (medical interview)
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: 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.
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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, M.D. 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 Poland.
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 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 Poland. 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: 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.