Seino Yoshihiko, Momomura Shin-Ichi, Kihara Yasuki, Adachi Hitoshi, Yasumura Yoshio, Yokoyama Hiroyuki
Department of Cardiology, Cardiovascular Center, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.
Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama, Saitama, 330-8503, Japan.
Trials. 2015 Jan 16;16:14. doi: 10.1186/s13063-014-0530-z.
Adaptive servo-ventilation (ASV) therapy, which is a form of noninvasive positive pressure ventilation therapy and uses an innovative ventilator that has simple operability and provides good patient adherence, potentially has therapeutic benefits-suppression of the deterioration and progression of chronic heart failure (CHF) and a reduction in the number of repeated hospitalizations. Therefore, ASV therapy draws attention as a novel, noninvasive nonpharmacotherapy for patients with CHF owing to its hemodynamics-improving effect, and it is currently being accepted in real-world clinical settings in Japan. However, clinical evidence sufficient for treatment recommendation is lacking because a multicenter, randomized, controlled study of ASV therapy has never been conducted.
METHODS/DESIGN: The present study is a confirmatory, prospective, multicenter, collaborative, open-label, blinded-endpoint, parallel-group, randomized, controlled study. At 40 medical institutions in Japan, 200 Japanese outpatients with mild to severe CHF (age: ≥ 20 years; New York Heart Association classification: greater than or equal to class II) will be randomly assigned to either of the following two study groups: the ASV group, in which 100 outpatients undergo guideline-directed medical therapy and ASV therapy for 24 weeks; and the control group, in which 100 outpatients undergo only guideline-directed medical therapy for 24 weeks. The objective of the present study is to confirm whether the ASV group is superior to the control group concerning the improvement of left ventricular contractility and remodeling, both assessed by two-dimensional echocardiography. Furthermore, the present study will also secondarily examine the effects of ASV therapy on the prognosis and quality of life of patients with CHF.
ASV therapy using the device has the potential to provide therapeutic benefits based on its simple operability and good patient adherence and possesses the potential to improve left ventricular contractility and remodeling. Therefore, the present study is expected to afford more solid scientific evidence regarding ASV therapy as a novel, noninvasive, nonpharmacological, in-home, long-term ventilation therapy for patients with mild to severe CHF.
UMIN identifier: UMIN000006549 , registered on 17 October, 2011.
适应性伺服通气（ASV）疗法是一种无创正压通气疗法，使用的创新型呼吸机操作简单，患者依从性良好，可能具有治疗益处——抑制慢性心力衰竭（CHF）的恶化和进展，并减少再次住院次数。因此，ASV疗法因其改善血流动力学的作用，作为一种针对CHF患者的新型无创非药物疗法而受到关注，目前在日本的实际临床环境中正在被接受。然而，由于从未进行过ASV疗法的多中心、随机、对照研究，因此缺乏足以推荐治疗的临床证据。
方法/设计：本研究是一项验证性、前瞻性、多中心、协作、开放标签、盲终点、平行组、随机、对照研究。在日本的40家医疗机构，200名轻度至重度CHF的日本门诊患者（年龄：≥20岁；纽约心脏协会分级：大于或等于II级）将被随机分配到以下两个研究组之一：ASV组，100名门诊患者接受指南指导的药物治疗和ASV治疗24周；对照组，100名门诊患者仅接受指南指导的药物治疗24周。本研究的目的是通过二维超声心动图评估，确认ASV组在改善左心室收缩力和重塑方面是否优于对照组。此外，本研究还将次要考察ASV疗法对CHF患者预后和生活质量的影响。
使用该设备的ASV疗法因其操作简单和患者依从性良好而有可能提供治疗益处，并且具有改善左心室收缩力和重塑的潜力。因此，本研究有望为ASV疗法作为一种针对轻度至重度CHF患者的新型、无创、非药物、居家、长期通气疗法提供更确凿的科学证据。
UMIN标识符：UMIN000006549，于2011年10月17日注册。
