OSA and CV Outcomes in Patients With High Risk AF
Recruiting · NCT04005508 · Observational (researchers observe without assigning treatment) · Lead sponsor: National University of Singapore
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age 22 or above
- Known AF, including paroxysmal, persistent or permanent AF
- 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
- Known OSA on regular CPAP treatment
- Valvular AF (moderate/severe mitral stenosis or mechanical heart valve)
- Permanent pacemaker implantation
- Life expectancy less than 1 year based on concomitant medical conditions
- Unable to give research consent
- Pregnant or lactating women
Where it is running
1 location listed.
- Chi-Hang Lee - Singapore, Singapore