Clinical trial NCT03866148: Obstructive Sleep Apnoea and Cardiac Arrhythmias
Official title: Obstructive Sleep Apnoea and Cardiac Arrhythmias and the Impact of an Implantable Loop Recorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Cardiovascular Diseases
Arrhythmia
Atrial Fibrillation New Onset
Keywords: Atrial Fibrillation
Obstructive Sleep Apnea
Implantable Loop Recorder
Extended Cardiac Monitoring
Matrix Metalloproteinase-9
Interleukin-6
Tumour Necrosis Factor-Alpha
High sensitivity C-Reactive Protein
High sensitivity Troponin-T
Fibroblast Growth Factor-23
Heart Rate Variability
N-Terminal pro B-type Natriuretic Peptide
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups with the intervention the difference.
Primary purpose: TREATMENT

Brief summary: This study is a prevelance trial looking at how sleep apnoea affects the heart especially heart rhythms.

Previous research shows that patients suffering from sleep apnoea are much more likely to get heart disease and abnormal heart rhythms (arrhythmias). These defects are sometimes missed by the traditional methods of monitoring i.e. 24-hour Holter monitor and ECGs. This means potentially dangerous arrhythmias may not be detected. Additionally, standard therapy for sleep apnoea does not significantly reduce the risk of heart disease.

This study will recruit 200 participants over a period of 18 months. The research team will observe the heart rhythms of sleep apnoea patients by inserting an implantable loop recorder (ILR) in up to 100 participants. The other 100 patients will simply have standard care. This device will monitor the heart continuously for 3 years allowing us to detect abnormal heart rhythms and treat as necessary.

Demonstrating the incidence of arrhythmia can lead onto a larger study which may change future sleep apnoea management improving their cardiovascular outcomes. Other markers of heart disease such as; blood tests, Magnetocardiography and Echocardiography will be performed on participants to shed more light on the mechanisms which link sleep apnoea and heart disease/arrhythmia.

Detailed description: Sleep apnoea affects up to 1.5 million adults in the United Kingdom (UK). This puts this population at risk of reduced oxygen levels during sleep, poor sleep and increased breathing effort . All of the above put stress on the body and are proven to increase the risk of high blood pressure, heart failure and vascular problems. This can lead to strokes, heart disease and death.

Sleep apnoea patients are at much higher risk of abnormal heart rhythms. Even with continuous positive airways pressure (CPAP) treatment (which is the mainstay in sleep apnoea and does help to reduce arrhythmias) patients are still at higher risk of heart disease and stroke.

An implantable loop recorder (Reveal-LINQ) inserted into sleep apnoea patients will be able to continuously monitor a patient's heart rhythm. This will determine the incidence of arrhythmia in sleep apnoea patients. Any significant abnormalities in either arm of the study will be treated as per National Health Service guidelines and best care. The cost associated with this method of intervention will also be considered.

If there is a high prevalence of arrhythmia a future larger trial, involving much larger numbers and multiple centres, could be conducted to demonstrate reduced risk of stroke or heart attack using this method of arrhythmia detection and management.

Cardiovascular biomarkers, cardiac function, autonomic function and magnetocardiography in these patients could shed light on the mechanisms which cause increased cardiovascular morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe sleep apnoea who require CPAP as standard care (AHI \>15)
* Patients between the age of 18 and 75

Exclusion Criteria:

* Patients with a diagnosis of atrial fibrillation (AF), atrial flutter and/or ventricular tachycardia (VT)
* Patients with an ILR already in-situ or an established indication for ILR
* Patients with a palliative diagnosis i.e. life expectancy less than 3 years
* Patients who lack capacity

Primary outcomes:
measure: Incidence of arrhythmia
timeFrame: 3 years
measure: Autonomic function before and after CPAP
timeFrame: 3 years
Secondary outcomes:
measure: Onset and frequency of atrial fibrillation
timeFrame: 3 years
measure: Rate of Cardiovascular Morbidity
timeFrame: 3 years
measure: Rate of Cardiovascular Mortality
timeFrame: 3 years
measure: Cardiovascular biomarkers before and after CPAP
timeFrame: 3 years
measure: Echocardiography before and after CPAP
timeFrame: 3 years
measure: Quality of life: EQ-5D-5L questionnaire
timeFrame: 3 years
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospital Coventry & Warwickshire
Study officials:
References:
citation: Yeung C, Drew D, Hammond S, Hopman WM, Redfearn D, Simpson C, Abdollah H, Baranchuk A. Extended Cardiac Monitoring in Patients With Severe Sleep Apnea and No History of Atrial Fibrillation (The Reveal XT-SA Study). Am J Cardiol. 2018 Dec 1;122(11):1885-1889. doi: 10.1016/j.amjcard.2018.08.032. Epub 2018 Sep 7.
citation: McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.
citation: Javaheri S, Barbe F, Campos-Rodriguez F, Dempsey JA, Khayat R, Javaheri S, Malhotra A, Martinez-Garcia MA, Mehra R, Pack AI, Polotsky VY, Redline S, Somers VK. Sleep Apnea: Types, Mechanisms, and Clinical Cardiovascular Consequences. J Am Coll Cardiol. 2017 Feb 21;69(7):841-858. doi: 10.1016/j.jacc.2016.11.069.