Carotid Body Removal for the Treatment of Resistant Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Procedure: Carotid body excision

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS2 8HW
    • Clinical Research and Imaging Centre (CRIC) and the Bristol Heart Institute (BHI), University Hospitals Bristol NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Blood Pressure	Change from Baseline Blood Pressure at 3 months	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Noblewell

Publications and helpful links

Helpful Links

• Unilateral Carotid Body Resection in Resistant Hypertension

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (ESTIMATE): December 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CBR-BRISTOL.UK-CIBIEM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES