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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Hypertension and Diabetology, Medical University of Gdansk

Gdansk, 80-952, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Change of Blood Pressure

Time frame: 3 months

Change from Baseline Blood Pressure at 3 months

Sponsors and collaborators

Lead sponsor

Noblewell

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Nov 21, 2012
Registry last updated: Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed