Carotid Body Removal for the Treatment of Resistant Hypertension

NCT ID: NCT01745172

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carotid body excision

Patients undergoing the carotid body excision to test the hypothesis that carotid body excision is sufficient to attain target blood pressure.

Group Type: EXPERIMENTAL

Carotid body excision

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Noblewell

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul A. Sobotka, MD

Role: STUDY_DIRECTOR

Cibiem, Inc.

Locations

Clinical Research and Imaging Centre (CRIC) and the Bristol Heart Institute (BHI), University Hospitals Bristol NHS Foundation Trust

Bristol, , United Kingdom

Countries

United Kingdom

Other Identifiers

CBR-BRISTOL.UK-CIBIEM

Identifier Type: -

Identifier Source: org_study_id