NCT04005508 OSA and CV Outcomes in Patients With High Risk AF
| NCT ID | NCT04005508 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Singapore |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,365 participants |
| Start Date | 2019-07-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,365 participants in total. It began in 2019-07-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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
Contact & Investigator
Chi-Hang R Lee, MD
PRINCIPAL INVESTIGATOR
National University of Singapore
Frequently Asked Questions
Who can join the NCT04005508 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 99 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04005508 currently recruiting?
Yes, NCT04005508 is actively recruiting participants. Contact the research team at shalilb@nus.edu.sg for enrollment information.
Where is the NCT04005508 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT04005508 clinical trial?
NCT04005508 is sponsored by National University of Singapore. The principal investigator is Chi-Hang R Lee, MD at National University of Singapore. The trial plans to enroll 1,365 participants.
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