OSA and CV Outcomes in Patients With High Risk AF

NCT04005508 | Recruiting

• 1 other identifier: POACH
• Study Type: observational
• Target: 1,365
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Atrial Fibrillation; Obstructive Sleep Apnea

Keywords

sleep; cardiovascular outcomes; high cardiovascular risk; observational

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization

  5 years

Secondary Outcomes (8)

• All-cause mortality

  5 years

• All-cause mortality, myocardial infarction, or stroke

  5 years

• Cardiovascular death

  5 years

• Cardiovascular death, myocardial infarction, or stroke

  5 years

• Ischemic stroke

  5 years

Study Arms (2)

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

Patients found to have OSA by an overnight sleep study

Diagnostic Test: Overnight sleep study

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

Interventions

Overnight sleep study DIAGNOSTIC_TEST

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

Non-OSA (Watch PAT AHI < 15 events per hour); OSA (Watch PAT AHI >/= 15 events per hour)

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AF and high cardiovascular risk

You may qualify if:

• 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,
• year risk of cardiovascular disease of 15% or greater on the basis of the Framingham risk score, or
• age of 75 years or older

You may not qualify if:

• Known OSA on regular CPAP treatment
• Valvular AF (moderate/severe mitral stenosis or mechanical heart valve)
• Permanent pacemaker implantation
• Life expectancy less than 1 year based on concomitant medical conditions
• Unable to give research consent
• Pregnant or lactating women

Sponsors & Collaborators

• National University of Singapore: lead
• Ng Teng Fong General Hospital: collaborator
• National University Hospital, Singapore: collaborator
• Singapore General Hospital: collaborator

Study Sites (1)

Chi-Hang Lee

Singapore, 119228, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Chi-Hang R Lee, MD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shalini Lobo, BSc

CONTACT

67795555; shalilb@nus.edu.sg

Junping Liu, BSc

CONTACT

67795555; junping_liu@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 2, 2019
• Study Start: July 1, 2019
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)