The POACH study is part of the Cardiosleep research program. It is a prospective, observational, multicentre study conducted in Singapore. The recruitment target is 1365 patients. Eligible patients with AF and high cardiovascular risk will be recruited for a home-based sleep study using a FDA-approved portable device. The patients will be divided into 2 groups based on the presence or absence of OSA using apnoea-hypopnoea index ≥ 15 events/hour. The AF will be treated as per local standard practice. Participation in the POACH study will not affect the management of AF. Follow-up will be conducted every 6 months until the median follow-up duration has reached 2 years. The primary endpoint is a four-component composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalisation. Antecubital venous blood samples will be taken from the patients in the morning after the sleep study for targeted mass spectrometry which will measure 83 circulating metabolites. Sparse Principal Component Analysis will be used for data reduction. Identification of distinct associations between metabolic perturbations and OSA will be performed.
The overarching objective of the POACH study is to determine the impact of obstructive sleep apnoea (OSA) on cardiovascular outcomes in patients with atrial fibrillation (AF). AF is the most prevalent sustained arrhythmia. While OSA often co-exists with AF, current management of AF does not take OSA status into consideration. This is partly due to the lack of data on whether OSA is independently associated with cardiovascular events in patients with AF. Besides, metabolomics is an emerging field of 'omics' research focusing on profiling and quantifying low-molecular weight components. The POACH study is part of the Cardiosleep research program. It is a prospective, observational, multicentre study conducted in Singapore. The recruitment target is 1365 patients. Eligible patients with AF and high cardiovascular risk will be recruited for a home-based sleep study using a FDA-approved portable device. The patients will be divided into 2 groups based on the presence or absence of OSA using apnoea-hypopnoea index ≥ 15 events/hour. The AF will be treated as per local standard practice. Follow-up will be conducted every 6 months until the median follow-up duration has reached 2 years. The primary endpoint is a four-component composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalisation. Antecubital venous blood samples will be taken from the patients in the morning after the sleep study for targeted mass spectrometry which will measure 83 circulating metabolites. Sparse Principal Component Analysis will be used for data reduction. Identification of distinct associations between metabolic perturbations and OSA will be performed. Results of the POACH study will likely impact the care of patients with AF.
Study Type
OBSERVATIONAL
Enrollment
1,365
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
Chi-Hang Lee
Singapore, Singapore
RECRUITINGMajor adverse cardiovascular events
Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization
Time frame: 5 years
All-cause mortality
Death due to any cause
Time frame: 5 years
All-cause mortality, myocardial infarction, or stroke
tripe composite endpoint
Time frame: 5 years
Cardiovascular death
Death due to cardiovascular cause
Time frame: 5 years
Cardiovascular death, myocardial infarction, or stroke
tripe composite endpoint
Time frame: 5 years
Ischemic stroke
Stroke is defined as global or focal cerebral, spinal cord or retinal injury resulting in acute neurological dysfunction due to ischemia
Time frame: 5 years
Heart failure hospitalisation
the presence of congestive heart failure being the primary disease process accounting for clinical and physical signs of heart failure, with a need for additional or increased heart failure therapy, requiring at least a 24 hour stay in an inpatient unit or emergency department
Time frame: 5 years
Recurrence of AF after attempts at rhythm control
Recurrence of AF after attempts at rhythm control (pharmacological, catheter, or cardioversion)
Time frame: 5 years
AF Progression
Defined as (1) paroxysmal AF at baseline becoming persistent or permanent at the last follow-up visit or (2) persistent AF at baseline becoming permanent at the last follow-up visit.
Time frame: 5 years
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