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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
Wroclaw, Poland
Peripheral chemosensitivity
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.
Time frame: 4 weeks
Muscle sympathetic nerve activity
Change from baseline in muscle sympathetic nerve activity at 4 weeks.
Time frame: 4 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 distance, New York Heart Association Class) at 4 weeks.
Time frame: 4 weeks
Quality of life
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks.
Time frame: 4 weeks
Serum concentration of NT-proBNP
Change from baseline in serum concentration of NT-proBNP at 4 weeks.
Time frame: 4 weeks
Barosensitivity
Change from baseline in barosensitivity at 4 weeks.
Time frame: 4 weeks
Peripheral chemosensitivity
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks.
Time frame: 8 weeks
Muscle sympathetic nerve activity
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Change from baseline in muscle sympathetic nerve activity at 8 weeks.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Quality of life
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks.
Time frame: 8 weeks
Heart function and morphology
Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks.
Time frame: 8 weeks
Serum concentration of NT-proBNP
Change from baseline in serum concentration of NT-proBNP at 8 weeks.
Time frame: 8 weeks
Barosensitivity
Change from baseline in barosensitivity at 8 weeks.
Time frame: 8 weeks
Arrhythmia burden
Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks.
Time frame: 8 weeks