Actively Recruiting
OSA and CV Outcomes in Patients With High Risk AF
Led by National University of Singapore · Updated on 2024-06-12
1365
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
Sponsors
N
National University of Singapore
Lead Sponsor
N
Ng Teng Fong General Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
OSA and CV Outcomes in Patients With High Risk AF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 or above
- Known atrial fibrillation, including paroxysmal, persistent, or permanent AF
- High cardiovascular risk defined by one or more of the following: hypertension, diabetes mellitus, stroke, significant coronary artery disease (≥50% stenosis in a major artery or positive stress test or previous coronary intervention/surgery), chronic kidney disease (excluding polycystic kidney disease) with eGFR <60 ml/min/1.73m2, 10-year cardiovascular disease risk ≥15% by Framingham risk score, or age 75 years or older
You will not qualify if you...
- Known obstructive sleep apnea on regular CPAP treatment
- Valvular atrial fibrillation (moderate/severe mitral stenosis or mechanical heart valve)
- Permanent pacemaker implantation
- Life expectancy less than 1 year due to other medical conditions
- Unable to provide research consent
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chi-Hang Lee
Singapore, Singapore, 119228
Actively Recruiting
Research Team
S
Shalini Lobo, BSc
CONTACT
J
Junping Liu, BSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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