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

Noblewell1 site in 1 country11 target enrollmentNovember 2012

ConditionsHypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: Noblewell
Enrollment: 11
Locations: 1
Primary Endpoint: Change of Blood Pressure
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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

November 2012

End Date

January 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

•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.