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

Study Overview
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Brief Summary
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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.

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

Conditions
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Systolic Heart Failure, Peripheral Chemoreceptor Hypersensitivity

Intervention / Treatment
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* Procedure: Bilateral Surgical Resection of Carotid Bodies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral Surgical Resection of Carotid Bodies<br>Patients undergoing Bilateral Surgical Resection of Carotid Bodies. | Procedure: Bilateral Surgical Resection of Carotid Bodies<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral chemosensitivity | Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks. | 4 weeks | 
| Muscle sympathetic nerve activity | Change from baseline in muscle sympathetic nerve activity at 4 weeks. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise tolerance | 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 distance, New York Heart Association Class) at 4 weeks. | 4 weeks | 
| Quality of life | Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks. | 4 weeks | 
| Serum concentration of NT-proBNP | Change from baseline in serum concentration of NT-proBNP at 4 weeks. | 4 weeks | 
| Barosensitivity | Change from baseline in barosensitivity at 4 weeks. | 4 weeks | 
| Peripheral chemosensitivity | Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks. | 8 weeks | 
| Muscle sympathetic nerve activity | Change from baseline in muscle sympathetic nerve activity at 8 weeks. | 8 weeks | 
| Exercise tolerance | 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. | 8 weeks | 
| Sleep pattern in PSG | 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. | 8 weeks | 
| Quality of life | Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks. | 8 weeks | 
| Heart function and morphology | Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks. | 8 weeks | 
| Serum concentration of NT-proBNP | Change from baseline in serum concentration of NT-proBNP at 8 weeks. | 8 weeks | 
| Barosensitivity | Change from baseline in barosensitivity at 8 weeks. | 8 weeks | 
| Arrhythmia burden | Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks. | 8 weeks |