Chi-Hang Lee
Singapore, 119228
Location status: Recruiting
NCT Number: NCT04005508
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.
Interested in participating?
Request Info22 year–99 year
All sexes
Observational
Singapore, 119228
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
Time frame: 5 years
Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization
Time frame: 5 years
Death due to any cause
Time frame: 5 years
tripe composite endpoint
Time frame: 5 years
Death due to cardiovascular cause
Time frame: 5 years
tripe composite endpoint
Time frame: 5 years
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
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 (pharmacological, catheter, or cardioversion)
Time frame: 5 years
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.
Contact information is provided by the study sponsor or research team.
National University of Singapore
Other
Prospective Study on Obstructive Sleep Apnea and Cardiovascular Outcomes in Patients With Atrial Fibrillation and High Cardiovascular Risk
Acronym: POACH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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