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):

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 : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study
Study Start Date : November 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 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: 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

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.

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 identifier (NCT number): NCT01729988

Department of Hypertension and Diabetology, Medical University of Gdansk
Gdansk, Poland, 80-952
Sponsors and Collaborators
Study Director: Paul A. Sobotka, M.D. Cibiem, Inc.

Additional Information:
Responsible Party: Noblewell Identifier: NCT01729988     History of Changes
Other Study ID Numbers: CBR-GDAPL-CIBIEM
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases