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OSA and CV Outcomes in Patients With High Risk AF

Recruitingn/aAges 22 Years - 99 YearsAllNational University of Singapore
NCT04005508 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 af

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 22 or above 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: 1. Known OSA on regular CPAP treatment 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
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What it tests

  • Overnight sleep study
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Where

1 site
Chi-Hang Lee
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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