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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

Tracking Information
First Submitted Date  ICMJE August 6, 2020
First Posted Date  ICMJE August 14, 2020
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE August 7, 2020
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • Change of AF burden [ Time Frame: 0, 6, 12 months ]
    The duration in AF on 14-day ECG monitor (percent)
  • change of left atrium volume [ Time Frame: 0, 6, 12 months ]
    LA volume index measured by ultrasonocardiography
  • 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%
  • Number of participants hospitalized for cardiovascular or all causes [ Time Frame: 12 months ]
    Hospitalization for cardiovascular or all causes within the follow-up period
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2020)
  • Change of AF burden [ Time Frame: 0, 6, 12 months ]
    The duration in AF on 14-day ECG monitor (%)
  • change of left atrium volume [ Time Frame: 0, 6, 12 months ]
    LA volume index measured by ultrasonocardiography
  • change of Quality of Life [ Time Frame: 0, 6, 12 months ]
    Questionairre (SF-36)
  • Number of participants hospitalized for cardiovascular or all causes [ Time Frame: 12 months ]
    Hospitalization for cardiovascular or all causes within the follow-up period
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CPAP in AF Patients With OSA
Official Title  ICMJE The Effect of Continuous Positive Airway Pressure in Patients With Obstructive Sleep Apnea and Paroxysmal Atrial Fibrillation
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Sleep Apnea
Intervention  ICMJE
  • Device: continuous positive airway pressure
    CPAP treatment at night. Treat AF as cardiologist's discretion.
  • Device: Placebo
    Observation. Treat AF as cardiologist's discretion.
Study Arms  ICMJE
  • Experimental: CPAP treatment for 12 months
    CPAP treatment for 12 months
    Intervention: Device: continuous positive airway pressure
  • Placebo Comparator: Placebo
    observation
    Intervention: Device: Placebo
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chih-Chieh C Yu, MD.PhD 886-2-23123456 ext 65257 sweetchieh@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04513483
Other Study ID Numbers  ICMJE 202002128RINC
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  ICMJE
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chih-Chieh Yu, MD.PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP