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.
Condition or disease | Intervention/treatment |
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Atrial Fibrillation Obstructive Sleep Apnea | Diagnostic Test: Overnight sleep 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.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 1365 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 5 Years |
Official Title: | Prospective Study on Obstructive Sleep Apnea and Cardiovascular Outcomes in Patients With Atrial Fibrillation and High Cardiovascular Risk |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | June 30, 2026 |
Group/Cohort | Intervention/treatment |
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OSA (Watch PAT AHI >/= 15 events per hour)
Patients found to have OSA by an overnight sleep study
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Diagnostic Test: Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
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Non-OSA (Watch PAT AHI < 15 events per hour)
Patients found NOT to have OSA by an overnight sleep study
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Diagnostic Test: Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
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Ages Eligible for Study: | 22 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
High cardiovascular risk, defined as one or more of the following:
Exclusion Criteria:
Contact: Sam Yuze Wang, BSc | 67795555 ext 2493 | mdcswy@nus.edu.sg | |
Contact: Junping Liu, BSc | 67795555 ext 2493 | junping_liu@nuhs.edu.sg |
Singapore | |
Chi-Hang Lee | Recruiting |
Singapore, Singapore, 119228 | |
Contact: Lee CH Ronald, MD 67722493 ext 22493 ronald_lee@nuhs.edu.sg |
Principal Investigator: | Chi-Hang Lee, MD | National University, Singapore |
Tracking Information | |||||||||
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First Submitted Date | June 29, 2019 | ||||||||
First Posted Date | July 2, 2019 | ||||||||
Last Update Posted Date | March 3, 2021 | ||||||||
Actual Study Start Date | July 1, 2019 | ||||||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Major adverse cardiovascular events [ Time Frame: 5 years ] Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | OSA and CV Outcomes in Patients With High Risk AF | ||||||||
Official Title | Prospective Study on Obstructive Sleep Apnea and Cardiovascular Outcomes in Patients With Atrial Fibrillation and High Cardiovascular Risk | ||||||||
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. |
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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. |
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Study Type | Observational [Patient Registry] | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 5 Years | ||||||||
Biospecimen | Retention: Samples Without DNA Description:
Blood samples
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Sampling Method | Non-Probability Sample | ||||||||
Study Population | Patients with AF and high cardiovascular risk | ||||||||
Condition |
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Intervention | Diagnostic Test: Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
1365 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | June 30, 2026 | ||||||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 22 Years to 99 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Singapore | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04005508 | ||||||||
Other Study ID Numbers | POACH | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Chi-Hang Lee, National University, Singapore | ||||||||
Study Sponsor | National University, Singapore | ||||||||
Collaborators |
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Investigators |
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PRS Account | National University, Singapore | ||||||||
Verification Date | March 2021 |