Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure

Not Applicable

Completed

• Conditions: Peripheral Chemoreceptor Hypersensitivity; Systolic Heart Failure
• Interventions: Procedure: Bilateral Surgical Resection of Carotid Bodies

• Registration Number: NCT01782677
• Lead Sponsor: Noblewell

Brief Summary

The primary aim of the study is to determine safety, tolerability and feasibility of bilateral carotid body resection in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of bilateral carotid body resection.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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
• 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
Bilateral Surgical Resection of Carotid Bodies	Bilateral Surgical Resection of Carotid Bodies	Patients undergoing Bilateral Surgical Resection of Carotid Bodies.

Primary Outcome Measures

Name	Time	Method
Muscle sympathetic nerve activity	4 weeks	Change from baseline in muscle sympathetic nerve activity at 4 weeks.
Peripheral chemosensitivity	4 weeks	Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Heart function and morphology	8 weeks	Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks.
Sleep pattern in PSG	8 weeks	Change from baseline in sleep pattern in PSG (apnoea-hypopnoea index, percentage of central and obstructive episodes, average oxygen saturation, number of arousals, average duration of apnoeic and hypopnoeic episodes) at 8 weeks.
Arrhythmia burden	8 weeks	Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks.
Exercise tolerance	8 weeks	Change from baseline in exercise tolerance (peak oxygen consumption, slope relating minute ventilation to carbon dioxide production, oxygen uptake efficiency slope, time of exercise, 6-minute walking test, New York Heart Association Class) at 8 weeks.
Quality of life	8 weeks	Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks.
Serum concentration of NT-proBNP	8 weeks	Change from baseline in serum concentration of NT-proBNP at 8 weeks.
Barosensitivity	8 weeks	Change from baseline in barosensitivity at 8 weeks.
Peripheral chemosensitivity	8 weeks	Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks.
Muscle sympathetic nerve activity	8 weeks	Change from baseline in muscle sympathetic nerve activity at 8 weeks.

Trial Locations

Locations (1)

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