An observational study in Sleep Disordered Breathing and Heart Failure, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Suspended at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-09.
Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Observational
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 215 are open to participants now.
This study's planned enrollment of 40 is below the median of 64 across 183 observational studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 137 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients with heart failure (EF\<40%) and moderate to severe CSA (\>15 events per hour, \>50% Central)
Device: CRT Implantation
Heart failure (EF \< 40%) but no significant sleep apnoea (\<5 events per hour).
Device: CRT Implantation
Implantation of a biventricular pacemaker or defibrillator.
Also known as: INVIVE, INCEPTA, AUTOGEN
The change in gradient of minute ventilation vs end tidal CO2 before and after CRT (the hypercapnic ventilatory response).
Time frame: 6 weeks and 6 months
6 minute walk distance
Time frame: 6 weeks and 6 months
Change in resting PaCO2
Time frame: 6 weeks and 6 months
Change in left ventricular ejection fraction
Time frame: 6 weeks and 6 months
Change in plasma B-Type Natriuretic Peptide level
Time frame: 6 weeks and 6 months
This study is suspended, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Royal Brompton & Harefield NHS Foundation Trust