Surgical Removal of Carotid Body in Patients With Systolic Heart Failure

Not Applicable

Completed

• Conditions: Peripheral Chemoreceptor Hypersensitivity; Systolic Heart Failure
• Interventions: Procedure: Carotid body excision

• Registration Number: NCT01653821
• Lead Sponsor: Noblewell

Brief Summary

The aim of the study is to determine safety, tolerability and feasibility of unilateral and bilateral carotid body excision in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Study Start: 2012-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• History of heart failure class II-III according to NYHA within at least 6 months prior to inclusion
• Stable clinical state within at least 4 weeks prior to inclusion
• Subject >= 18 years old
• Left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (Simpson's method)
• Carotid body present in computer cervical angiotomography
• History of exacerbated peripheral chemoreceptor sensitivity determined as >0.6L/min/%SpO2
• Able and willing to give written informed consent

Exclusion Criteria

• Unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to inclusion
• History of stroke, transient ischemic attack (TIA), or clinically significant chronic neurological disorder
• History of heart transplant
• Pregnancy or anticipation of pregnancy
• Hemodialysis or peritoneal dialysis patients
• Obstructive carotid atherosclerotic disease with >50% stenosis
• Severe sleep apnea syndrome diagnosed in PSG
• COPD stage III and IV according to GOLD 2007
• Unable to perform the spiroergometric assessment
• Any significant anomaly in additional investigation which may increase the risk of study procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carotid body excision	Carotid body excision	Patients undergoing unilateral or bilateral removal of carotid body.

Primary Outcome Measures

Name	Time	Method
Peripheral chemosensitivity	4 weeks	Ventilatory response to hypoxia using transient inhalation of nitrogen.

Trial Locations

Locations (1)

Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny; 🇵🇱 Wroclaw, Poland