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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Noblewell
ClinicalTrials.gov Identifier:
NCT01729988
First received: November 8, 2012
Last updated: May 23, 2014
Last verified: May 2014

November 8, 2012
May 23, 2014
November 2012
December 2015   (final data collection date for primary outcome measure)
Change of Blood Pressure [ Time Frame: 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 NCT01729988 on ClinicalTrials.gov 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
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.
 
Active, not recruiting
25
Not Provided
December 2015   (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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01729988
CBR-GDAPL-CIBIEM
Yes
Noblewell
Noblewell
Not Provided
Study Director: Paul A. Sobotka, M.D. Cibiem, Inc.
Noblewell
May 2014

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