Heart Failure, Sleep-Disordered Breathing
Conditions
Keywords
Sleep-Disordered Breathing, Sleep Apnoea, Heart failure
Brief summary
Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing for periods whilst asleep, is common in heart failure and associated with a poor prognosis. This study aims to validate a novel function available on certain pacemakers which is designed to detect this condition.The investigators hypothesize that ApneaScan can accurately detect moderate to severe sleep disordered breathing in patients with heart failure as compared against an Embletta sleep study. The investigators will also follow up our patients for 2 years to determine whether the severity of sleep disordered breathing as assessed by ApneaScan correlates with prognosis.
Detailed description
72 patients with heart failure with reduced ejection fraction (HFREF) who have been selected to receive an Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Pacemaker or Defibrillator (CRT-P/D) will undergo pre-implant assessment with an echocardiogram, B-type Natriuretic Peptide (BNP) level, 6 minute walk test, Minnesota living with heart failure and Epworth sleepiness questionnaires. The patients will then have the device implanted. 6 to 8 weeks later the patent will undergo an Embletta home sleep study and download of the ApneaScan data from the device. The mean Apnoea-Hypopnoea Index (AHI) from the ApneaScan download will be compared with that derived from the sleep study. The patients will also have a repeat 6 minute walk test, echocardiogram and BNP level. 2 years after device implantation, all patients will be followed up to document deaths, hospital admissions, Atrial Fibrillation (AF) burden and appropriate therapies from ICD devices.
Interventions
DEVICEPacemaker/ICD
Implantation of an ICD or CRT device with ApneaScan function
Sponsors
Boston Scientific Corporation
Royal Brompton & Harefield NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Heart failure with reduced ejection fraction (EF \< 40%) * Due to receive a device with ApneaScan function * Able to give informed consent * Ambulatory
Exclusion criteria
* Known sleep disordered breathing on Non-Invasive Ventilation therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Apnoeic-Hypopnoeic Index (AHI) | 18 months | We will compare that AHI from the ApneaScan pacemaker algorithm against the AHI from an Embletta sleep study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse heart failure events | 2 years | Comprising hospital admissions for heart failure, AF burden, VF and VT burden and mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| B-Type Natriuretic peptide (BNP) concentration | 2 years | BNP concentration correlated with severity of SDB |
| Ejection fraction on echocardiography | 2 years | Correlation of ejection fraction and severity of SDB |
| 6 minute walk test distance | 2 years | Correlation between 6MWTd and severity of SDB |
Countries
United Kingdom
Contacts
Primary ContactSimon G Pearse, MBChB
Backup ContactAli Vazir, MBBS
Outcome results
None listed