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.
|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 Resistant Hypertension: a Pilot Study|
- Change of Blood Pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Change from Baseline Blood Pressure at 3 months
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01729988
|Department of Hypertension and Diabetology, Medical University of Gdansk|
|Gdansk, Poland, 80-952|
|Study Director:||Paul A. Sobotka, M.D.||Cibiem, Inc.|