OSA and CV Outcomes in Patients With High Risk AF
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.
| Condition(s) | Atrial Fibrillation, Obstructive Sleep Apnea |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 h |
| Who can participate | 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 |
| Ages | 22 Years to 99 Years |
| Sex | All |
| Lead sponsor | National University of Singapore |
| Locations | Singapore, Singapore |
| Start date | 2019-07-01 |
| NCT ID | NCT04005508 |
| Official listing | https://clinicaltrials.gov/study/NCT04005508 |