Actively Recruiting

Age: 22Years - 99Years
All Genders
NCT04005508

OSA and CV Outcomes in Patients With High Risk AF

Led by National University of Singapore · Updated on 2024-06-12

1365

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

Sponsors

N

National University of Singapore

Lead Sponsor

N

Ng Teng Fong General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

OSA and CV Outcomes in Patients With High Risk AF

Who Can Participate

Age: 22Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 22 or above
  • Known atrial fibrillation, including paroxysmal, persistent, or permanent AF
  • High cardiovascular risk defined by one or more of the following: hypertension, diabetes mellitus, stroke, significant coronary artery disease (≥50% stenosis in a major artery or positive stress test or previous coronary intervention/surgery), chronic kidney disease (excluding polycystic kidney disease) with eGFR <60 ml/min/1.73m2, 10-year cardiovascular disease risk ≥15% by Framingham risk score, or age 75 years or older
Not Eligible

You will not qualify if you...

  • Known obstructive sleep apnea on regular CPAP treatment
  • Valvular atrial fibrillation (moderate/severe mitral stenosis or mechanical heart valve)
  • Permanent pacemaker implantation
  • Life expectancy less than 1 year due to other medical conditions
  • Unable to provide research consent
  • Pregnant or lactating women

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chi-Hang Lee

Singapore, Singapore, 119228

Actively Recruiting

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Research Team

S

Shalini Lobo, BSc

CONTACT

J

Junping Liu, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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