OSA and CV Outcomes in Patients With High Risk AF

Atrial Fibrillation Clinical Trial

— POACH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04005508
• Other study ID #: POACH
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: June 30, 2028

Study information

• Verified date: June 2024
• Source: National University of Singapore
• Contact: Shalini Lobo, BSc
• Phone: 67795555
• Email: shalilb[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1365
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Overnight sleep study
The patients will undergo an overnight sleep study using Watch-PAT sleep study device

Locations

Country	Name	City	State
Singapore	Chi-Hang Lee	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
National University of Singapore	National University Hospital, Singapore, Ng Teng Fong General Hospital, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	Composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalization	5 years
Secondary	All-cause mortality	Death due to any cause	5 years
Secondary	All-cause mortality, myocardial infarction, or stroke	tripe composite endpoint	5 years
Secondary	Cardiovascular death	Death due to cardiovascular cause	5 years
Secondary	Cardiovascular death, myocardial infarction, or stroke	tripe composite endpoint	5 years
Secondary	Ischemic stroke	Stroke is defined as global or focal cerebral, spinal cord or retinal injury resulting in acute neurological dysfunction due to ischemia	5 years
Secondary	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	5 years
Secondary	Recurrence of AF after attempts at rhythm control	Recurrence of AF after attempts at rhythm control (pharmacological, catheter, or cardioversion)	5 years
Secondary	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.	5 years