Carotid Body Removal for the Treatment of Resistant Hypertension
This study has been completed.
Information provided by (Responsible Party):
First received: November 22, 2012
Last updated: October 14, 2016
Last verified: October 2016
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.
Procedure: Carotid body excision
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Carotid Body Removal for the Treatment of Chronic Diseases Characterized by Excessive Central Sympathetic Activity Including Resistant Hypertension: a Pilot Study.
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2016 (Final data collection date for primary outcome measure)
Experimental: Carotid body excision
Patients undergoing the carotid body excision to test the hypothesis that carotid body excision is sufficient to attain target blood pressure.
Procedure: Carotid 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.
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745172
|Clinical Research and Imaging Centre (CRIC) and the Bristol Heart Institute (BHI), University Hospitals Bristol NHS Foundation Trust
|Bristol, United Kingdom, BS2 8HW |
||Paul A. Sobotka, MD
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 22, 2012
||October 14, 2016
||United Kingdom: Research Ethics Committee
|Individual Participant Data
|Plan to Share IPD:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 27, 2016