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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Procedure: Carotid body excision

• Registration Number: NCT01729988
• Lead Sponsor: Noblewell

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-21
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carotid body excision	Carotid body excision	Patients undergoing the carotid body excision to test the hypothesis that carotid body excision is sufficient to attain target blood pressure.

Primary Outcome Measures

Name	Time	Method
Change of Blood Pressure	3 months	Change from Baseline Blood Pressure at 3 months

Trial Locations

Locations (1)

Department of Hypertension and Diabetology, Medical University of Gdansk; 🇵🇱 Gdansk, Poland