Prospective Study on Obstructive Sleep Apnea and Cardiovascular Outcomes in Patients With Atrial Fibrillation and High Cardiovascular Risk

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Singapore
Chi-Hang Lee
RECRUITING
Singapore
Contact Information
Primary
Shalini Lobo, BSc
shalilb@nus.edu.sg
67795555
Backup
Junping Liu, BSc
junping_liu@nuhs.edu.sg
67795555
Time Frame
Start Date: 2019-07-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 1365
Treatments
OSA (Watch PAT AHI >/= 15 events per hour)
Patients found to have OSA by an overnight sleep study
Non-OSA (Watch PAT AHI < 15 events per hour)
Patients found NOT to have OSA by an overnight sleep study
Sponsors
Leads: National University of Singapore
Collaborators: Singapore General Hospital, Ng Teng Fong General Hospital, National University Hospital, Singapore

This content was sourced from clinicaltrials.gov