POACH: OSA and CV Outcomes in Patients With High Risk AF

Sponsor

National University, Singapore (Other)

Overall Status

Recruiting

CT.gov ID

NCT04005508

Collaborator

Ng Teng Fong General Hospital (Other), National University Hospital, Singapore (Other), Singapore General Hospital (Other), Tan Tock Seng Hospital (Other), Sengkang General Hospital (Other)

1,365

Enrollment

Location

Anticipated Duration (Months)

16.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Obstructive Sleep Apnea	Diagnostic Test: Overnight sleep study

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1365 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
OSA (Watch PAT AHI >/= 15 events per hour) Patients found to have OSA by an overnight sleep study	Diagnostic Test: Overnight sleep study The patients will undergo an overnight sleep study using Watch-PAT sleep study device
Non-OSA (Watch PAT AHI < 15 events per hour) Patients found NOT to have OSA by an overnight sleep study	Diagnostic Test: Overnight sleep study The patients will undergo an overnight sleep study using Watch-PAT sleep study device

Arm

Intervention/Treatment

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

Patients found to have OSA by an overnight sleep study

Diagnostic Test: Overnight sleep study

The patients will undergo an overnight sleep study using Watch-PAT sleep study device

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

Patients found NOT to have OSA by an overnight sleep study

Diagnostic Test: Overnight sleep study

The patients will undergo an overnight sleep study using Watch-PAT sleep study device

Outcome Measures

Primary Outcome Measures

Major adverse cardiovascular events [5 years]
Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization

Secondary Outcome Measures

All-cause mortality [5 years]
Death due to any cause
All-cause mortality, myocardial infarction, or stroke [5 years]
tripe composite endpoint
Cardiovascular death [5 years]
Death due to cardiovascular cause
Cardiovascular death, myocardial infarction, or stroke [5 years]
tripe composite endpoint
Ischemic stroke [5 years]
Stroke is defined as global or focal cerebral, spinal cord or retinal injury resulting in acute neurological dysfunction due to ischemia
Heart failure hospitalisation [5 years]
the presence of congestive heart failure being the primary disease process accounting for clinical and physical signs of heart failure, with a need for additional or increased heart failure therapy, requiring at least a 24 hour stay in an inpatient unit or emergency department
Recurrence of AF after attempts at rhythm control [5 years]
Recurrence of AF after attempts at rhythm control (pharmacological, catheter, or cardioversion)
AF Progression [5 years]
Defined as (1) paroxysmal AF at baseline becoming persistent or permanent at the last follow-up visit or (2) persistent AF at baseline becoming permanent at the last follow-up visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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