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CPAP in AF Patients With OSA (CPAPAF)

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ClinicalTrials.gov Identifier: NCT04513483
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Obstructive sleep apnea is associated with atrial fibrillation. This study is to evaluate the effect of continuous positive airway pressure on the burden of atrial fibrillation in the patients with obstructive sleep apnea and paroxysmal atrial fibrillation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Sleep Apnea Device: continuous positive airway pressure Device: Placebo Not Applicable

Detailed Description:

Traditional risk factors for AF were established from the original Framingham Heart Study cohort which showed aging, hypertension, congestive heart failure, coronary artery disease, valvular heart disease and diabetes mellitus (DM) as independent risk factors. In the past decade, several important risk factors not encompassed in previous studies have also been found to have a link with AF. One of these newly-identified risk factors is obstructive sleep apnea (OSA), which has been listed as one of the risk factor needed to be assessed and treated in AF patients.

OSA and AF often co-exist and indeed share some risk factors, such as hypertension. AF Patients are more likely to have OSA, with reported prevalence rates of OSA (apnea-hypopnea index [AHI] ≥15) as high as 62% in AF cohorts from hospital-based studies. In community-based cohort studies, a cross-sectional analysis from sleep heart health study (SHSS) found those with sleep-disordered breathing(SDB)/sleep apnea (SA) (respiratory disturbance index [RDI] ≥ 30) had four times the odds of a polysomnography (PSG)-detected nocturnal AF as compared to those without SDB/SA after adjusting confounders. Following from this, a cross-sectional study on Outcomes of Sleep Disorders in Older Men Study (MrOS Sleep Study) showed a dose-response association between RDI and AF.

There are several pathophysiological mechanisms by which OSA could potentially increase the risk of development of new AF, or trigger a recurrence of AF in a patient with an established history of AF. OSA is characterized by repetitive collapse of the upper airway (UA) during sleep. The UA collapses when sleep-related loss in UA dilator muscle tone is superimposed upon a narrow and/or collapsible airway. These obstructive apneas or hypopneas, characterized by unsuccessful inspiratory efforts against an occluded airway, lead to 1) exaggerated negative intrathoracic pressure swings 2) hypoxia, and 3) co-activation of sympathetic and parasympathetic systems, all of which have been shown to potentiate a pro-arrhythmic state. Given that these mechanisms are pro-arrhythmic, CPAP (continuous positive airway pressure), the gold standard therapy for OSA, works by splinting the upper airway open during sleep with subsequent abolition of swings in pressure, hypoxia and arousals, can potentially modify the risk of development of AF or recurrence of AF in OSA patients.

There is a growing body of literature supporting that OSA being as a risk factor for recurrence of AF after cardioversion or ablation and treatment of OSA with CPAP decreased the risk of recurrence of AF. Nevertheless, all of the aforementioned studies are observational or retrospective in nature. Recently, Caples et al. conducted the first randomized control trial using CPAP in patients with AF and OSA but failed to find a difference of recurrence of AF between those treated with CPAP versus usual care. Notably, there are several issues in the study design and methodology that do not allow for firm conclusion from the results of this study. It was a single-center study, enrolling very small number of patients, and used a low cut-off AHI>5/h as inclusion criteria. More importantly, only patients with persistent AF scheduled for cardioversion were included. Given the natural time-course from paroxysmal AF to persistent AF, long-term remodeling or established atrial arrythmogenic substrate in persistent AF may be less or not reversible even when the initial risk factor is removed. In this regard, early intervention with CPAP in patients with paroxysmal AF and OSA, which has never been done in previous studies, should confer a better antiarrythmic effect. Therefore, the investigators aim to test the hypothesis that treatment of OSA with CPAP would reduce the burden of AF in patients with paroxysmal AF.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Continuous Positive Airway Pressure in Patients With Obstructive Sleep Apnea and Paroxysmal Atrial Fibrillation
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CPAP treatment for 12 months
CPAP treatment for 12 months
Device: continuous positive airway pressure
CPAP treatment at night. Treat AF as cardiologist's discretion.

Placebo Comparator: Placebo
observation
Device: Placebo
Observation. Treat AF as cardiologist's discretion.




Primary Outcome Measures :
  1. Change of AF burden [ Time Frame: 0, 6, 12 months ]
    The duration in AF on 14-day ECG monitor (percent)

  2. change of left atrium volume [ Time Frame: 0, 6, 12 months ]
    LA volume index measured by ultrasonocardiography

  3. change of Quality of Life [ Time Frame: 0, 6, 12 months ]
    Questionnaire (Short Form Health Survey-36); higher scores means a better quality of life; maximal score 100%

  4. Number of participants hospitalized for cardiovascular or all causes [ Time Frame: 12 months ]
    Hospitalization for cardiovascular or all causes within the follow-up period



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. men or women aged 20 to 65 years
  2. paroxysmal AF, diagnosed based on the ACC/AHA/HRS 2014 guideline, and is defined as AF that terminates spontaneously or with intervention within 7 d of onset either by 12-lead EKG, 24-hr Holter, or 14-day ECG monitor.
  3. OSA, defined as an AHI>15/hr of sleep, of which >50% of events are obstructive.
  4. Informed consent signed

Exclusion Criteria:

  1. Moderate-severe valvular heart diseases (regurgitation or stenosis)
  2. post heart surgery
  3. Uncontrolled systemic hypertension or pulmonary hypertension
  4. Use of psychoactive or other drugs that could influence breathing patterns
  5. Current use of CPAP treatment
  6. Epworth sleepiness scale>10
  7. Congestive heart failure (LVEF≦45%)
  8. Chronic obstructive pulmonary disease
  9. History of stroke or neuromuscular disease
  10. Severe insomnia

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): NCT04513483


Contacts
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Contact: Chih-Chieh C Yu, MD.PhD 886-2-23123456 ext 65257 sweetchieh@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chih-Chieh Yu, MD.PhD.    886-2-23123456 ext 65257    sweetchieh@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chih-Chieh Yu, MD.PhD National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04513483    
Other Study ID Numbers: 202002128RINC
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: July 2020
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 National Taiwan University Hospital:
Atrial Fibrillation
sleep apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases