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临床试验/JPRN-jRCTs032180344
JPRN-jRCTs032180344招募中未知

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

Kasai Takatoshi0 个研究点目标入组 64 人开始时间: 2019年3月18日最近更新:

试验速览

阶段
未知
状态
招募中
发起方
入组人数
64

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
All

入选标准

  • 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

排除标准

  • 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)
  • 11)Non-compliant patients (determined during tolerability test period, <70 % and <4 hrs/night will be non-compliant)
  • 12)Non-suitable patients judged by principal investigator

研究者

发起方
Kasai Takatoshi

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