OSA and CV Outcomes in Patients With High Risk AF (POACH)

National University of Singapore

Status: Enrolling

Conditions: Atrial Fibrillation; Obstructive Sleep Apnea

Treatments: Diagnostic Test: Overnight sleep study

Study type: Observational

Funder types: Other

Identifiers

NCT04005508

POACH

Details and patient eligibility

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.

Full description

The overarching objective of the POACH study is to determine the impact of obstructive sleep apnoea (OSA) on cardiovascular outcomes in patients with atrial fibrillation (AF).

AF is the most prevalent sustained arrhythmia. While OSA often co-exists with AF, current management of AF does not take OSA status into consideration. This is partly due to the lack of data on whether OSA is independently associated with cardiovascular events in patients with AF. Besides, metabolomics is an emerging field of 'omics' research focusing on profiling and quantifying low-molecular weight components.

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. 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.

Results of the POACH study will likely impact the care of patients with AF.

Enrollment: 1,365 estimated patients

Sex: All

Ages: 22 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,365 participants in 2 patient groups

OSA (Watch PAT AHI >/= 15 events per hour)

Description:

Patients found to have OSA by an overnight sleep study

Treatment:

Diagnostic Test: Overnight sleep study

Non-OSA (Watch PAT AHI < 15 events per hour)

Description:

Patients found NOT to have OSA by an overnight sleep study

Treatment:

Diagnostic Test: Overnight sleep study