Carotid Body Removal for the Treatment of Resistant Hypertension

Hypertension Clinical Trial

Official title:

Carotid Body Removal for the Treatment of Chronic Diseases Characterized by Excessive Central Sympathetic Activity Including Resistant Hypertension: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745172
• Other study ID #: CBR-BRISTOL.UK-CIBIEM
• Status: Completed
• Phase: N/A
• First received: November 22, 2012
• Last updated: October 14, 2016
• Start date: January 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Noblewell
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. The principle research question is whether removal of the carotid body will lead to an improvement in the blood pressure of this patient group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Clinical Research and Imaging Centre (CRIC) and the Bristol Heart Institute (BHI), University Hospitals Bristol NHS Foundation Trust	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
Noblewell

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Blood Pressure	Change from Baseline Blood Pressure at 3 months	Baseline and 3 months	Yes

External Links

•   Unilateral Carotid Body Resection in Resistant Hypertension