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

NCT01729988 | Completed DMC

• 1 other identifier: CBR-GDAPL-CIBIEM
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change of Blood Pressure

  Change from Baseline Blood Pressure at 3 months

  3 months

Study Arms (1)

Carotid body excision

EXPERIMENTAL

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

Interventions

Carotid body excision PROCEDURE

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.

Carotid body excision

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Noblewell: lead

Study Sites (1)

Department of Hypertension and Diabetology, Medical University of Gdansk

Gdansk, 80-952, Poland

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paul A. Sobotka, M.D.

  Cibiem, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

PL (1)