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

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ClinicalTrials.gov Identifier: NCT04005508
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborators:
Ng Teng Fong General Hospital
National University Hospital, Singapore
Singapore General Hospital
National Heart Centre Singapore
Information provided by (Responsible Party):
Chi-Hang Lee, National University, Singapore

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. Sleep tracings will be scored by a sleep physician. 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.


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 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. Sleep tracings will be scored by a sleep physician. 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]
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

Resource links provided by the National Library of Medicine


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




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


Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005508


Contacts
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Contact: Chi-Hang Lee, MD 67795555 ext 2493 mdclchr@nus.edu.sg
Contact: Junping Liu, BSc junping_liu@nuhs.edu.sg

Locations
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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
National Heart Centre Singapore
Investigators
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Principal Investigator: Chi-Hang Lee, MD National University, Singapore

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Responsible Party: Chi-Hang Lee, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT04005508     History of Changes
Other Study ID Numbers: POACH
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi-Hang Lee, National University, Singapore:
sleep
cardiovascular outcomes
high cardiovascular risk
observational
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases