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Pending further equipment and staff
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated contraction of the heart, has been shown to reduce the severity of CSA in some patient groups. We aim to determine whether this improvement is due to normalization of the body's response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by normalizing the brain's response to carbon dioxide.
Sleep disordered Breathing is common in heart failure, affecting around half of patients. This may be Obstructive Sleep Apnoea due to loss of pharyngeal muscle tone (OSA, associated with obesity and snoring and predisposing to hypertension, heart attack and stroke) or Central Sleep Apnoea (CSA). CSA is particularly prevalent in severe heart failure and associated with an adverse prognosis. The mechanism involves reflex hyperventilation due to pulmonary oedema, exaggerated chemosensor response to hypercapnoea associated with increased sympathetic nervous system activation and a prolonged circulation time.
It is known that CRT improved CSA in 'responders' but the mechanism is unknown. We hypothesis that CRT normalizes the respiratory response to carbon dioxide (the hypercapnic ventilatory response - HCVR).
We will screen patients undergoing CRT with an Embletta sleep study to identify a group with moderate to severe CSA and a group with no sleep apnoea (controls). Patients will undergo assessment of the hypercapnic ventilatory response with a Read Re-Breathe test prior to device implantation and 6 weeks and 6 months afterwards. The gradient of minute ventilation vs PaCO2 will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pts with CSA for CRT implantation | Patients with heart failure (EF<40%) and moderate to severe CSA (>15 events per hour, >50% Central) |
| |
| No Sleep Apnoea for CRT implantation | Heart failure (EF < 40%) but no significant sleep apnoea (<5 events per hour). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT Implantation | Device | Implantation of a biventricular pacemaker or defibrillator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in gradient of minute ventilation vs end tidal CO2 before and after CRT (the hypercapnic ventilatory response). | 6 weeks and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walk distance | 6 weeks and 6 months | |
| Change in resting PaCO2 | 6 weeks and 6 months | |
| Change in left ventricular ejection fraction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with heart failure with reduced ejection fraction (<40% on echocardiography) due to undergo implantation of a biventricular pacemaker, with either no significant sleep disordered breathing or moderate to severe CSA.
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| Name | Affiliation | Role |
|---|---|---|
| Ali Vazir, PhD | Imperial College. Royal Brompton Hospital | Principal Investigator |
| Martin Cowie, MD | Imperial College London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton and Harefield NHS Foundation Trust | London | SW6 6NP | United Kingdom |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D006333 | Heart Failure |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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|
| 6 weeks and 6 months |
| Change in plasma B-Type Natriuretic Peptide level | 6 weeks and 6 months |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |