Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1365 participants
OBSERVATIONAL
2019-07-01
2028-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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OSA (Watch PAT AHI >/= 15 events per hour)
Patients found to have OSA by an overnight sleep study
Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
Non-OSA (Watch PAT AHI < 15 events per hour)
Patients found NOT to have OSA by an overnight sleep study
Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
Interventions
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Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
Eligibility Criteria
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Inclusion Criteria
2. Known AF, including paroxysmal, persistent or permanent AF
3. High cardiovascular risk, defined as one or more of the following:
* hypertension
* diabetes mellitus
* stroke
* significant coronary artery disease (at least one stenosis of \>50% diameter in at least one major epicardial artery based on CT or conventional coronary angiography, positive stress test \[treadmill, myocardial perfusion scan, or stress echocardiography\], previous percutaneous coronary intervention, or previous coronary artery bypass surgery)
* chronic kidney disease (excluding polycystic kidney disease) with an estimated glomerular filtration rate of \<60 ml/min/1.73m2,
* 10-year risk of cardiovascular disease of 15% or greater on the basis of the Framingham risk score, or
* age of 75 years or older
Exclusion Criteria
2. Valvular AF (moderate/severe mitral stenosis or mechanical heart valve)
3. Permanent pacemaker implantation
4. Life expectancy less than 1 year based on concomitant medical conditions
5. Unable to give research consent
6. Pregnant or lactating women
22 Years
99 Years
ALL
No
Sponsors
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Ng Teng Fong General Hospital
OTHER
National University Hospital, Singapore
OTHER
Singapore General Hospital
OTHER
National University of Singapore
OTHER
Responsible Party
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Chi-Hang Lee
Professor
Principal Investigators
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Chi-Hang R Lee, MD
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore
Locations
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Chi-Hang Lee
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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POACH
Identifier Type: -
Identifier Source: org_study_id
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