Impact of sleep apnea on heart health in patients with atrial fibrillation
Prospective Study on Obstructive Sleep Apnea and Cardiovascular Outcomes in Patients With Atrial Fibrillation and High Cardiovascular Risk
This study is testing how sleep apnea affects heart health in people with atrial fibrillation to see if it changes their risk of heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1365 (estimated) |
| Ages | 22 Years to 99 Years |
| Sex | All |
| Sponsor | National University of Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04005508 on ClinicalTrials.gov |
What this trial studies
The POACH study aims to investigate how obstructive sleep apnea (OSA) affects cardiovascular outcomes in patients with atrial fibrillation (AF) who are at high cardiovascular risk. This prospective, observational study will recruit 1365 patients in Singapore, using a home-based sleep study to classify participants based on the presence of OSA. Patients will receive standard AF management, and follow-up assessments will occur every six months for up to two years. The study will also analyze blood samples to measure various metabolites that may provide insights into cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 22 and above with known atrial fibrillation and high cardiovascular risk factors.
Not a fit: Patients who are already on regular CPAP treatment for known obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular risks in patients with atrial fibrillation and sleep apnea.
How similar studies have performed: While the relationship between OSA and cardiovascular outcomes is being explored, this specific approach in patients with AF is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore
- Chi-Hang Lee — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Chi-Hang R Lee, MD — National University of Singapore
- Study coordinator: Shalini Lobo, BSc
- Email: shalilb@nus.edu.sg
- Phone: 67795555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.