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Carotid Body Removal for the Treatment of Resistant Hypertension

This study is currently recruiting participants.
Verified January 2013 by Noblewell
Sponsor:
Information provided by (Responsible Party):
Noblewell
ClinicalTrials.gov Identifier:
NCT01745172
First received: November 22, 2012
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Hypertension
 Procedure: Carotid body excision

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Noblewell:

Primary Outcome Measures:
  • Change of Blood Pressure [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]
    Change from Baseline Blood Pressure at 3 months


Estimated Enrollment: 10
Study Start Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745172

Contacts
Contact: Angus Nightingale, MD Angus.Nightingale@UHBristol.nhs.uk

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

No publications provided

Responsible Party: Noblewell
ClinicalTrials.gov Identifier: NCT01745172     History of Changes
Other Study ID Numbers: CBR-BRISTOL.UK-CIBIEM
Study First Received: November 22, 2012
Last Updated: January 21, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013