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
  Purpose

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 Intervention
Hypertension
Procedure: Carotid body excision

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Noblewell:

Primary Outcome Measures:
  • Change of Blood Pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Change from Baseline Blood Pressure at 3 months


Estimated Enrollment: 25
Study Start Date: November 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729988

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

No publications provided

Responsible Party: Noblewell
ClinicalTrials.gov Identifier: NCT01729988     History of Changes
Other Study ID Numbers: CBR-GDAPL-CIBIEM
Study First Received: November 8, 2012
Last Updated: May 23, 2014
Health Authority: Poland: Ethics Committee

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014