Carotid Body Removal for the Treatment of Resistant Hypertension

NCT01745172 | Completed DMC

• 1 other identifier: CBR-BRISTOL.UK-CIBIEM
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change of Blood Pressure

  Change from Baseline Blood Pressure at 3 months

  Baseline and 3 months

Study Arms (1)

Carotid body excision

EXPERIMENTAL

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

Interventions

Carotid body excision 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.

Carotid body excision

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Noblewell: lead

Study Sites (1)

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

Bristol, BS2 8HW, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paul A. Sobotka, MD

  Cibiem, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: December 10, 2012
• Study Start: January 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)