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Clinical Trials/NCT01745172
NCT01745172
Completed
Not Applicable

Carotid Body Removal for the Treatment of Chronic Diseases Characterized by Excessive Central Sympathetic Activity Including Resistant Hypertension: a Pilot Study.

Noblewell1 site in 1 country4 target enrollmentJanuary 2013
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Noblewell
Enrollment
4
Locations
1
Primary Endpoint
Change of Blood Pressure
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Noblewell
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age of participants will be 18-75 years
  • Resistant HTN criteria:
  • Daytime mean ambulatory systolic blood pressure ≥135mmHg and office systolic blood pressure ≥150mmHg
  • Patients on at least three anti-hypertensive medications, including a diuretic, at maximum tolerated dose
  • No evidence of causes for secondary HTN following thorough clinical assessment
  • Patient medication concordance will be monitored via medication/blood pressure diary

Exclusion Criteria

  • Calculated GFR \<45ml/min/1.73m2
  • Carotid body located outside the defined carotid septum
  • Obstructive carotid atherosclerotic disease with \>50% stenosis
  • Oxygen desaturation at rest below 92%
  • Known structural lung disease
  • 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

Outcomes

Primary Outcomes

Change of Blood Pressure

Time Frame: Baseline and 3 months

Change from Baseline Blood Pressure at 3 months

Study Sites (1)

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