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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral Surgical Resection of Carotid Bodies | Experimental | Patients undergoing Bilateral Surgical Resection of Carotid Bodies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Surgical Resection of Carotid Bodies | Procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Ponikowski, Prof. | 4. Wojskowy Szpital Kliniczny we Wroclawiu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centrum ChoroĢb Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny | Wroclaw | 50-981 | Poland |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |