Hypertension
Conditions
Brief 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. The principle research question is whether removal of the carotid body will lead to an improvement in the blood pressure of this patient group.
Interventions
PROCEDURECarotid body excision
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.
Sponsors
Noblewell
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age of participants will be 18-75 years * Resistant HTN criteria: 1. Daytime mean ambulatory systolic blood pressure ≥135mmHg and office systolic blood pressure ≥150mmHg 2. Patients on at least three anti-hypertensive medications, including a diuretic, at maximum tolerated dose 3. No evidence of causes for secondary HTN following thorough clinical assessment 4. Patient medication concordance will be monitored via medication/blood pressure diary
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Blood Pressure | Baseline and 3 months | Change from Baseline Blood Pressure at 3 months |
Countries
United Kingdom
Outcome results
None listed