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出境医 / 临床实验 / OSA and CV Outcomes in Patients With High Risk AF (POACH)

OSA and CV Outcomes in Patients With High Risk AF (POACH)

Study Description
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.


Condition or disease Intervention/treatment
Atrial Fibrillation Obstructive Sleep Apnea Diagnostic Test: Overnight sleep study

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
Layout table for study information
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
Arms and Interventions
Group/Cohort Intervention/treatment
OSA (Watch PAT AHI >/= 15 events per hour)
Patients found to have OSA by an overnight sleep study
Diagnostic Test: Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device

Non-OSA (Watch PAT AHI < 15 events per hour)
Patients found NOT to have OSA by an overnight sleep study
Diagnostic Test: Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device

Outcome Measures
Primary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: 5 years ]
    Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization


Secondary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Blood samples

Eligibility Criteria
Layout table for eligibility information
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
Study Population
Patients with AF and high cardiovascular risk
Criteria

Inclusion Criteria:

  1. Age 22 or above
  2. Known AF, including paroxysmal, persistent or permanent AF
  3. 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:

  1. Known OSA on regular CPAP treatment
  2. Valvular AF (moderate/severe mitral stenosis or mechanical heart valve)
  3. Permanent pacemaker implantation
  4. Life expectancy less than 1 year based on concomitant medical conditions
  5. Unable to give research consent
  6. Pregnant or lactating women
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sam Yuze Wang, BSc 67795555 ext 2493 mdcswy@nus.edu.sg
Contact: Junping Liu, BSc 67795555 ext 2493 junping_liu@nuhs.edu.sg

Locations
Layout table for location information
Singapore
Chi-Hang Lee Recruiting
Singapore, Singapore, 119228
Contact: Lee CH Ronald, MD    67722493 ext 22493    ronald_lee@nuhs.edu.sg   
Sponsors and Collaborators
National University, Singapore
Ng Teng Fong General Hospital
National University Hospital, Singapore
Singapore General Hospital
Tan Tock Seng Hospital
Sengkang General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chi-Hang Lee, MD National University, Singapore
Tracking Information
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
 (submitted: July 1, 2019)
Major adverse cardiovascular events [ Time Frame: 5 years ]
Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2019)
  • All-cause mortality [ Time Frame: 5 years ]
    Death due to any cause
  • All-cause mortality, myocardial infarction, or stroke [ Time Frame: 5 years ]
    tripe composite endpoint
  • Cardiovascular death [ Time Frame: 5 years ]
    Death due to cardiovascular cause
  • Cardiovascular death, myocardial infarction, or stroke [ Time Frame: 5 years ]
    tripe composite endpoint
  • 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
  • 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
  • Recurrence of AF after attempts at rhythm control [ Time Frame: 5 years ]
    Recurrence of AF after attempts at rhythm control (pharmacological, catheter, or cardioversion)
  • 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.
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.

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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Patients with AF and high cardiovascular risk
Condition
  • Atrial Fibrillation
  • Obstructive Sleep Apnea
Intervention Diagnostic Test: Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device
Study Groups/Cohorts
  • OSA (Watch PAT AHI >/= 15 events per hour)
    Patients found to have OSA by an overnight sleep study
    Intervention: 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
    Intervention: Diagnostic Test: Overnight sleep study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 1, 2019)
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:

  1. Age 22 or above
  2. Known AF, including paroxysmal, persistent or permanent AF
  3. 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:

  1. Known OSA on regular CPAP treatment
  2. Valvular AF (moderate/severe mitral stenosis or mechanical heart valve)
  3. Permanent pacemaker implantation
  4. Life expectancy less than 1 year based on concomitant medical conditions
  5. Unable to give research consent
  6. Pregnant or lactating women
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sam Yuze Wang, BSc 67795555 ext 2493 mdcswy@nus.edu.sg
Contact: Junping Liu, BSc 67795555 ext 2493 junping_liu@nuhs.edu.sg
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Chi-Hang Lee, National University, Singapore
Study Sponsor National University, Singapore
Collaborators
  • Ng Teng Fong General Hospital
  • National University Hospital, Singapore
  • Singapore General Hospital
  • Tan Tock Seng Hospital
  • Sengkang General Hospital
Investigators
Principal Investigator: Chi-Hang Lee, MD National University, Singapore
PRS Account National University, Singapore
Verification Date March 2021