Effects of adaptive servo-ventilation therapy on cardiac function and remodeling in patients with chronic heart failure (SAVIOR-C): study protocol for a randomized controlled trial.
BACKGROUND
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
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.


CONCLUSIONS
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.


BACKGROUND
UMIN identifier: UMIN000006549 , registered on 17 October, 2011.
Department of Cardiology, Cardiovascular Center, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan. y-seino@nms.ac.jp.
Yoshihiko
Y
Seino
Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama, Saitama, 330-8503, Japan. momochan-tky@umin.net.
Shin-Ichi
S
Momomura
Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical & Health Sciences, 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, 734-8551, Japan. ykihara@hiroshima-u.ac.jp.
Yasuki
Y
Kihara
Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kamiizumi-machi, Maebashi, Gunma, 371-0004, Japan. h-adachi@ops.dti.ne.jp.
Hitoshi
H
Adachi
Cardiovascular Division, Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan. yasumura@onh.go.jp.
Yoshio
Y
Yasumura
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka, 565-8565, Japan. hiyokoya@hctv.ne.jp.
Hiroyuki
H
Yokoyama
D000368:Aged; D002908:Chronic Disease; D002985:Clinical Protocols; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009200:Myocardial Contraction; D063087:Noninvasive Ventilation / Q000379:methods*; D011175:Positive-Pressure Respiration / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D012720:Severity of Illness Index; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D020257:Ventricular Remodeling