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Clinical Trials/JPRN-jRCTs032180344
JPRN-jRCTs032180344
Recruiting
未知

Short-term effect of positive airway pressure therapy in patients with atrial fibrillation (AF) and sleep-disordered breathing (SDB) - SYNERGY-AF

Kasai Takatoshi0 sites64 target enrollmentMarch 18, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Kasai Takatoshi
Enrollment
64
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 18, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kasai Takatoshi

Eligibility Criteria

Inclusion Criteria

  • 1\)Adults (age of 20 or greater)
  • 2\)Patients with AF (paroxysmal, persistent, and permanent)
  • 3\)Moderate to severe SDB (i.e. AHI15\-39 by home polygraphy test)
  • 4\) plasma BNP \>40pg/mL or NT\-proBNP \>125pg/m

Exclusion Criteria

  • 1\)LV systolic dysfunction (LV ejection fraction less than or equal to 45% on echocardiogram)
  • 2\)Severe organic valvular diseases
  • 3\)Acute coronary syndrome within 3 months
  • 4\)Patients who underwent or planned for following treatments within 3 months from randomization: pacemaker; implantable cardiac defibrillator (ICD); cardiac resynchronization therapy (CRT); cardiac surgery; percutaneous coronary intervention (PCI); transcatheter aortic valve intervention (TAVI)
  • 5\)Life\-threatening diseases (uncured malignancy, severe chronic pulmonary diseases with oxygen inhalation or specific medication, and end stage renal disease with dialysis)
  • 6\)Patients who received for PAP therapy within 2 weeks
  • 7\)Epworth sleepiness scale(ESS) greater than or equal to 11 or occupational driver
  • 8\)Pregnancy
  • 9\)Symptomatic OSA patients with class1 indication for PAP therapy in guidelines for diagnosis and treatment of acute and chronic heart failure (JCS 2017/JHFS 2017\)
  • 10\)Patients eligible for CPAP initiation with reimbursement (AHI greater than or equal to 40\)

Outcomes

Primary Outcomes

Not specified

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