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Carotid Body Removal for the Treatment of Resistant Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Noblewell
Sponsor:
Information provided by (Responsible Party):
Noblewell
ClinicalTrials.gov Identifier:
NCT01745172
First received: November 22, 2012
Last updated: August 28, 2013
Last verified: August 2013

November 22, 2012
August 28, 2013
January 2013
December 2013   (final data collection date for primary outcome measure)
Change of Blood Pressure [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]
Change from Baseline Blood Pressure at 3 months
Same as current
Complete list of historical versions of study NCT01745172 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
December 2013   (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)
Both
18 Years to 75 Years
No
Contact: Angus Nightingale, MD Angus.Nightingale@UHBristol.nhs.uk
United Kingdom
 
NCT01745172
CBR-BRISTOL.UK-CIBIEM
Yes
Noblewell
Noblewell
Not Provided
Study Director: Paul A. Sobotka, MD Cibiem, Inc.
Noblewell
August 2013

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