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
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