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Carotid Body Removal for the Treatment of Resistant Hypertension

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ClinicalTrials.gov Identifier: NCT01745172
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Noblewell

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.

Condition or disease Intervention/treatment Phase
Hypertension Procedure: Carotid body excision Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carotid Body Removal for the Treatment of Chronic Diseases Characterized by Excessive Central Sympathetic Activity Including Resistant Hypertension: a Pilot Study.
Study Start Date : January 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

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.





Primary Outcome Measures :
  1. Change of Blood Pressure [ Time Frame: Baseline and 3 months ]
    Change from Baseline Blood Pressure at 3 months



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745172


Locations
United Kingdom
Clinical Research and Imaging Centre (CRIC) and the Bristol Heart Institute (BHI), University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8HW
Sponsors and Collaborators
Noblewell
Investigators
Study Director: Paul A. Sobotka, MD Cibiem, Inc.

Additional Information:
Responsible Party: Noblewell
ClinicalTrials.gov Identifier: NCT01745172     History of Changes
Other Study ID Numbers: CBR-BRISTOL.UK-CIBIEM
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases