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NCT Number: NCT04005508

OSA and CV Outcomes in Patients With High Risk AF

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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

Treatment and study plan

Overnight sleep study

Diagnostic Test

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

Primary outcomes

  1. Major adverse cardiovascular events

    Time frame: 5 years

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

Secondary outcomes

  1. All-cause mortality

    Time frame: 5 years

    Death due to any cause

  2. All-cause mortality, myocardial infarction, or stroke

    Time frame: 5 years

    tripe composite endpoint

  3. Cardiovascular death

    Time frame: 5 years

    Death due to cardiovascular cause

  4. Cardiovascular death, myocardial infarction, or stroke

    Time frame: 5 years

    tripe composite endpoint

  5. Ischemic stroke

    Time frame: 5 years

    Stroke is defined as global or focal cerebral, spinal cord or retinal injury resulting in acute neurological dysfunction due to ischemia

  6. Heart failure hospitalisation

    Time frame: 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

  7. Recurrence of AF after attempts at rhythm control

    Time frame: 5 years

    Recurrence of AF after attempts at rhythm control (pharmacological, catheter, or cardioversion)

  8. AF Progression

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Junping Liu, BSc

CONTACT

[email protected]

67795555 ext. 2493

Shalini Lobo, BSc

CONTACT

[email protected]

67795555 ext. 2493

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • National University Hospital, Singapore
  • Ng Teng Fong General Hospital
  • Singapore General Hospital

Registry information

Official study title

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

Acronym: POACH

Important dates

Study start
2019
Primary completion
2025
Study completion
2028
First posted
Jul 2, 2019
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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