Clinical trial NCT04005508: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Obstructive Sleep Apnea
Keywords: sleep
cardiovascular outcomes
high cardiovascular risk
observational
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ng Teng Fong General Hospital
name: National University Hospital, Singapore
name: Singapore General Hospital
First posted: 2019-07-02
Enrollment: 1365
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AF 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.

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

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 5 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: 5 years
measure: All-cause mortality, myocardial infarction, or stroke
timeFrame: 5 years
measure: Cardiovascular death
timeFrame: 5 years
measure: Cardiovascular death, myocardial infarction, or stroke
timeFrame: 5 years
measure: Ischemic stroke
timeFrame: 5 years
measure: Heart failure hospitalisation
timeFrame: 5 years
measure: Recurrence of AF after attempts at rhythm control
timeFrame: 5 years
measure: AF Progression
timeFrame: 5 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Chi-Hang Lee
Study officials:
affiliation: National University of Singapore
name: Chi-Hang R Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: