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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Obstructive Sleep Apnea
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1365

Contacts and Locations

• Study Contact: Name: Sam Yuze Wang, BSc; Phone Number: 2493 67795555; Email: mdcswy@nus.edu.sg
• Study Contact Backup: Name: Junping Liu, BSc; Phone Number: 2493 67795555; Email: junping_liu@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119228
    • Recruiting
    • Chi-Hang Lee
    • Contact: Lee CH Ronald, MD; Phone Number: 22493 67722493; Email: ronald_lee@nuhs.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with AF and high cardiovascular risk

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events	Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death due to any cause	5 years
All-cause mortality, myocardial infarction, or stroke	tripe composite endpoint	5 years
Cardiovascular death	Death due to cardiovascular cause	5 years
Cardiovascular death, myocardial infarction, or stroke	tripe composite endpoint	5 years
Ischemic stroke	Stroke is defined as global or focal cerebral, spinal cord or retinal injury resulting in acute neurological dysfunction due to ischemia	5 years
Heart failure hospitalisation	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	5 years
Recurrence of AF after attempts at rhythm control	Recurrence of AF after attempts at rhythm control (pharmacological, catheter, or cardioversion)	5 years
AF Progression	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.	5 years

Collaborators and Investigators

• Sponsor: National University, Singapore
• Collaborators: National University Hospital, Singapore; Singapore General Hospital; Tan Tock Seng Hospital; Sengkang General Hospital; Ng Teng Fong General Hospital
• Investigators: Principal Investigator: Chi-Hang Lee, MD, National University, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: June 29, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: sleep; observational; cardiovascular outcomes; high cardiovascular risk
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Arrhythmias, Cardiac; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Atrial Fibrillation
• Other Study ID Numbers: POACH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No