Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study

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: NCT01729988
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : October 18, 2016
Information provided by (Responsible Party):

November 8, 2012
November 21, 2012
October 18, 2016
November 2012
January 2016   (Final data collection date for primary outcome measure)
Change of Blood Pressure [ Time Frame: 3 months ]
Change from Baseline Blood Pressure at 3 months
Same as current
Complete list of historical versions of study NCT01729988 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study
Carotid Body Removal for the Treatment of 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2016
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Resistant HTN criteria with either confirmed sleep disordered breathing. Definition of HTN:Office SBP ≥ 160 mmHg and daytime mean ABPM ≥ 140 mm Hg
  • Definition of sleep disordered breathing: SDB defined as mild to moderate obstructive, central or mixed sleep apnea defined as 5 < AHI < 30 with O2 desaturation not exceeding 80% during the night.

Exclusion Criteria:

  • Calculated GFR < 30
  • Carotid body located outside the defined carotid septum
  • Obstructive carotid atherosclerotic disease
  • Oxygen desaturation at rest below 92%
  • Known structural lung disease (medical interview)
  • 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 < 6 months prior to procedure
  • Use of exogenous insulin AND history of hypoglycemic unawareness
  • Stroke or transient ischaemic attack (TIA), or myocardial infarction < 6 months prior to procedure
  • Expected life expectancy less that 24months due to other disease
  • Intravenous drug use
  • Excessive use of alcohol or sedatives (Alcohol intake >28 units/week)
  • Obesity (BMI > 40)
  • Upper airway or facial abnormalities
  • Large neck circumference (>43.2 cm men; >40.6 cm women)
  • Febrile illness within two weeks of participation
  • Unable to attend for follow up appointments at 1, 3 and 6 months post operatively.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Study Director: Paul A. Sobotka, M.D. Cibiem, Inc.
October 2016

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