Department of Cardiology, Tongren Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200336, China.
Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, 200030, China.
Am J Cardiovasc Drugs. 2019 Apr;19(2):211-218. doi: 10.1007/s40256-018-0304-1.
Our objective was to explore the effects of tolvaptan as a new therapeutic approach in patients with right heart failure with tricuspid insufficiency (TI).
This prospective, multicenter, non-randomized controlled pilot study enrolled patients (N = 40) with TI from the Shanghai Chest Hospital and Shanghai Tongren Hospital who fulfilled inclusion criteria between March 2015 and June 2016. Participants were assigned to receive either tolvaptan combined with torasemide (n = 20) or torasemide monotherapy (n = 20; control group). The primary endpoints were changes in patient weight and in tricuspid annular plane systolic excursion (TAPSE) after 10 days of treatment. The secondary endpoints included net fluid balance and cardiac functions before and after medication from the first to the tenth day of treatment. Safety was evaluated by monitoring adverse and serious adverse events.
TAPSE significantly increased in the tolvaptan group compared with the control group after 10 days of medication (P = 0.029). Daily weight losses in the tolvaptan group significantly increased as the time of treatment increased (time × group, P = 0.022). Recovery to New York Heart Association (NYHA) grade I occurred 4 days earlier in the tolvaptan group. In addition, the net fluid balance and median net fluid balance were significantly higher in the tolvaptan group. Eight adverse events and one serious adverse event were recorded in the tolvaptan group and 15 adverse events were recorded in the control group.
Our results indicate that tolvaptan might be a useful and safe drug to improve heart function in patients with right heart failure with TI after left heart valve replacement.
ClinicalTrials.gov identifier no. NCT02644616.
本研究旨在探讨托伐普坦作为一种新的治疗方法在伴有三尖瓣关闭不全（TI）的右心衰竭患者中的作用。
这项前瞻性、多中心、非随机对照的初步研究纳入了 2015 年 3 月至 2016 年 6 月期间上海胸科医院和上海仁济医院符合纳入标准的 40 例 TI 患者。参与者被分为托伐普坦联合托拉塞米组（n=20）或托拉塞米单药组（对照组，n=20）。主要终点为治疗 10 天后患者体重和三尖瓣环平面收缩期位移（TAPSE）的变化。次要终点包括治疗第 1 天至第 10 天药物治疗前后的净液体平衡和心功能。通过监测不良事件和严重不良事件来评估安全性。
与对照组相比，托伐普坦组治疗 10 天后 TAPSE 显著增加（P=0.029）。托伐普坦组的每日体重减轻量随治疗时间的增加而增加（时间×组，P=0.022）。托伐普坦组纽约心脏协会（NYHA）心功能分级恢复至 I 级的时间提前了 4 天。此外，托伐普坦组的净液体平衡和中位数净液体平衡均显著较高。托伐普坦组发生 8 例不良事件和 1 例严重不良事件，对照组发生 15 例不良事件。
我们的研究结果表明，托伐普坦可能是一种有用且安全的药物，可改善左心瓣膜置换术后伴有 TI 的右心衰竭患者的心功能。
ClinicalTrials.gov 标识符：NCT02644616。
