Atrial FibrillationPOACHNCT04005508
OSA and CV Outcomes in Patients With High Risk AF
An observational study of Atrial Fibrillation and Obstructive Sleep Apnea, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 99 years
- Conditions the study is for
- Atrial Fibrillation, Obstructive Sleep Apnea
- What is being tested?
- Overnight sleep study
- How many people
- 1,365 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2019to 30 Jun 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AF and high cardiovascular risk
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Chi-Hang Lee
Singapore, 119228
Lee CH Ronald, MD, 67722493 ext. 22493, ronald_lee@nuhs.edu.sg
About this study
Official title: Prospective Study on Obstructive Sleep Apnea and Cardiovascular Outcomes in Patients With Atrial Fibrillation and High Cardiovascular Risk
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea
- Being tested
- Overnight sleep study
- Keywords
- sleep, cardiovascular outcomes, high cardiovascular risk, observational
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight sleep studyDiagnostic test
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
| Study group | Role | What they receive |
|---|---|---|
| OSA (Watch PAT AHI >/= 15 events per hour) | Patients found to have OSA by an overnight sleep study Receives: 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 Receives: Diagnostic Test: Overnight sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization
Measured: 5 years
Secondary outcomes (8)
All-cause mortality
Death due to any cause
Measured: 5 years
All-cause mortality, myocardial infarction, or stroke
tripe composite endpoint
Measured: 5 years
Cardiovascular death
Death due to cardiovascular cause
Measured: 5 years
Cardiovascular death, myocardial infarction, or stroke
tripe composite endpoint
Measured: 5 years
Ischemic stroke
Stroke is defined as global or focal cerebral, spinal cord or retinal injury resulting in acute neurological dysfunction due to ischemia
Measured: 5 years
Heart failure hospitalisation
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
Measured: 5 years
Recurrence of AF after attempts at rhythm control
Recurrence of AF after attempts at rhythm control (pharmacological, catheter, or cardioversion)
Measured: 5 years
AF Progression
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Jul 2019
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,365 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ng Teng Fong General Hospital, National University Hospital, Singapore, Singapore General Hospital
- Responsible party
- Principal investigator, Chi-Hang Lee, National University of Singapore
- Investigators
- Chi-Hang R Lee, MD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005508
- Sponsor's protocol ID
- POACH
- Acronym
- POACH
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2019
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Obstructive Sleep Apnea and Cardiovascular Outcomes in Patients With Atrial Fibrillation and High Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT04005508
- Acronym / sponsor ID
- POACH / POACH
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea
- Keywords
- sleep, cardiovascular outcomes, high cardiovascular risk, observational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,365 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ng Teng Fong General Hospital, National University Hospital, Singapore, Singapore General Hospital
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA (Watch PAT AHI >/= 15 events per hour) | – | Diagnostic Test: Overnight sleep studyPatients found to have OSA by an overnight sleep study |
| Non-OSA (Watch PAT AHI < 15 events per hour) | – | Diagnostic Test: Overnight sleep studyPatients found NOT to have OSA by an overnight sleep study |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AF and high cardiovascular risk
Key inclusion criteria (10 listed)
- Age 22 or above
- Known AF, including paroxysmal, persistent or permanent AF
- High cardiovascular risk, defined as one or more of the following:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overnight sleep studyThe patients will undergo an overnight sleep study using Watch-PAT sleep study device | Diagnostic test | Non-OSA (Watch PAT AHI < 15 events per hour), OSA (Watch PAT AHI >/= 15 events per hour) |
Primary outcome
Major adverse cardiovascular events
Time frame: 5 years
Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization
8 secondary outcomes
All-cause mortality
Time frame: 5 years
All-cause mortality, myocardial infarction, or stroke
Time frame: 5 years
Cardiovascular death
Time frame: 5 years
Cardiovascular death, myocardial infarction, or stroke
Time frame: 5 years
Ischemic stroke
Time frame: 5 years
Heart failure hospitalisation
Time frame: 5 years
Recurrence of AF after attempts at rhythm control
Time frame: 5 years
AF Progression
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi-Hang R Lee, MD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Obstructive Sleep Apnea, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shalini Lobo, BSc (67795555 ext. 2493, shalilb@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.