NCT04005508Recruiting
OSA and CV Outcomes in Patients With High Risk AF
Prospective Study on Obstructive Sleep Apnea and Cardiovascular Outcomes in Patients With Atrial Fibrillation and High Cardiovascular Risk
Source: ClinicalTrials.gov · Last updated 12 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1365 (estimated)
- First submitted
- 29 Jun 2019
- Start date
- 1 Jul 2019
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- National University of Singapore
- Diseases
- Atrial fibrillation
- NCT number
- NCT04005508
What you commit to
- Study type: Observational
- Planned participants: 1365
- From 1 Jul 2019 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Life expectancy less than 1 year based on concomitant medical conditions
Other illness
- Valvular AF (moderate/severe mitral stenosis or mechanical heart valve)
Other
- Known OSA on regular CPAP treatment
- Permanent pacemaker implantation
- Unable to give research consent
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 22 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chi-Hang Lee Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.