Carotid Body Removal for the Treatment of Resistant Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745172
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : October 18, 2016
Information provided by (Responsible Party):

November 22, 2012
December 10, 2012
October 18, 2016
January 2013
May 2016   (Final data collection date for primary outcome measure)
Change of Blood Pressure [ Time Frame: Baseline and 3 months ]
Change from Baseline Blood Pressure at 3 months
Same as current
Complete list of historical versions of study NCT01745172 on Archive Site
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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.
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Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

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.
Intervention: Procedure: Carotid body excision
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2016
May 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Plan to Share IPD: Yes
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Study Director: Paul A. Sobotka, MD Cibiem, Inc.
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP