Peripheral Chemoreceptor Hypersensitivity, Systolic Heart Failure
Conditions
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.
Interventions
PROCEDUREBilateral Surgical Resection of Carotid Bodies
Sponsors
Noblewell
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration of NT-proBNP | 4 weeks | Change from baseline in serum concentration of NT-proBNP at 4 weeks. |
| Barosensitivity | 4 weeks | Change from baseline in barosensitivity at 4 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. |
| Exercise tolerance | 4 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 distance, New York Heart Association Class) at 4 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. |
| Heart function and morphology | 8 weeks | Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks. |
| Arrhythmia burden | 8 weeks | Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks. |
| Muscle sympathetic nerve activity | 8 weeks | Change from baseline in muscle sympathetic nerve activity at 8 weeks. |
| Quality of life | 4 weeks | Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks. |
Countries
Poland
Outcome results
None listed