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OSA and CV Outcomes in Patients With High Risk AF

NCT04005508 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1365

Last updated 2024-06-12

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Overnight sleep study

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

Sponsors & Collaborators

  • Ng Teng Fong General Hospital

    collaborator OTHER

  • National University Hospital, Singapore

    collaborator OTHER

  • Singapore General Hospital

    collaborator OTHER

  • National University of Singapore

    lead OTHER

Principal Investigators

  • Chi-Hang R Lee, MD · National University of Singapore

Eligibility

Min Age
22 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2025-06-30
Completion
2028-06-30

Countries

  • Singapore

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04005508 on ClinicalTrials.gov