Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Sleep and Sleep Disordered Breathing Center, Juntendo University Hospital, Tokyo, Japan.
J Cardiol. 2019 Jul;74(1):90-94. doi: 10.1016/j.jjcc.2018.12.021. Epub 2019 Feb 5.
Suvorexant, an orexin receptor antagonist, is known as a safe and effective sleep medication. Many patients with heart failure (HF) have sleep-disordered breathing (SDB) and are short sleepers, and it is unknown whether suvorexant is effective in HF patients and can improve insomnia safely. The aim of this study is to examine the effect of suvorexant on SDB in patients with HF.
The Heart Failure with Insomnia and Suvorexant trial of Juntendo University Hospital and Juntendo Shizuoka Hospital (J-FLAVOR trial) is a multicenter trial with a randomized double crossover design. We will enroll a total of 30 HF patients treated in the Juntendo University Hospital and Juntendo Shizuoka Hospital. Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order. Before the study night, patients in the suvorexant first group will receive suvorexant for 4 consecutive days. There are at least 3 wash-out days between the study nights with and without suvorexant. Primary outcome measures of the non-inferiority trial of suvorexant include the apnea-hypopnea index and the severity of SDB, and the results will be compared between the study nights with and without suvorexant.
The present study can determine whether suvorexant can be used in HF patients without affecting their SDB. This is a pilot study to primarily assess whether suvorexant affects the severity of SDB in patients with HF. Therefore, further study is warranted to investigate whether suvorexant alters short- and long-term clinical outcomes by providing longer and better sleep in patients with HF.
苏沃雷生是一种食欲素受体拮抗剂，已被证实为安全有效的助眠药物。许多心力衰竭（HF）患者存在睡眠呼吸障碍（SDB）和睡眠不足，目前尚不清楚苏沃雷生对 HF 患者是否有效，以及是否能安全改善失眠。本研究旨在探讨苏沃雷生对 HF 患者 SDB 的影响。
顺天堂大学医院和顺天堂静冈医院的心力衰竭伴失眠和苏沃雷生试验（J-FLAVOR 试验）是一项多中心、随机双交叉设计的试验。我们将共纳入 30 例在顺天堂大学医院和顺天堂静冈医院接受治疗的 HF 患者。符合条件的患者将接受两次便携式睡眠监测，两次监测均采用随机分组的方式，分别在口服苏沃雷生前后进行。在研究前夜之前，苏沃雷生第一组的患者将连续 4 天服用苏沃雷生。两次研究夜之间至少有 3 天的洗脱期。苏沃雷生非劣效性试验的主要结局指标包括呼吸暂停-低通气指数和 SDB 严重程度，比较有、无苏沃雷生时的研究夜结果。
本研究可确定苏沃雷生是否可用于 HF 患者而不影响其 SDB。这是一项初步评估苏沃雷生是否影响 HF 患者 SDB 严重程度的研究。因此，有必要进一步研究以探讨苏沃雷生是否通过为 HF 患者提供更长更好的睡眠来改变其短期和长期临床结局。
