Gao Wei-Qin, Meng Xiang-Dong, Sun Ze
First Ward of Cardiology Department, First Affiliated Hospital of Jiamusi University, Jiamusi, China.
Medicine (Baltimore). 2019 Feb;98(7):e14540. doi: 10.1097/MD.0000000000014540.
The protocol of this study will be proposed for systematic evaluation of the efficacy and safety of tolvaptan in the treatment of chronic heart failure (CHF).
We will retrieve the following electronic databases for randomized controlled trials assessing the efficacy of tolvaptan in patients with CHF: PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, Scopus, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Information, and Wanfang Data. Each database will be retrieved from inception to February 1, 2019 without any limitations. The entire process of study selection, data extraction, and methodological quality evaluation will be conducted by 2 independent authors.
The protocol of this proposed study will compare the efficacy and safety of tolvaptan in the treatment of patients with CHF. The outcomes will include all-cause mortality, change in body weight, urine output, change in serum sodium; and incidence of all adverse events.
The findings of this proposed study will summarize the current evidence of tolvaptan for CHF.
All data used in this systematic review will be collected from the previous published trials. Thus, no research ethics approval is needed for this study. The findings of this study will be published at a peer-reviewed journal.
PROSPERO CRD42019120818.
本研究方案将用于系统评价托伐普坦治疗慢性心力衰竭（CHF）的疗效和安全性。
我们将检索以下电子数据库，以获取评估托伐普坦对CHF患者疗效的随机对照试验：PubMed、Embase、Cochrane对照试验中心注册库、Web of Science、Scopus、中国生物医学文献数据库、中国知网、维普资讯和万方数据。每个数据库将从建库至2019年2月1日进行检索，无任何限制。研究选择、数据提取和方法学质量评估的整个过程将由2名独立作者进行。
本拟议研究方案将比较托伐普坦治疗CHF患者的疗效和安全性。结局指标将包括全因死亡率、体重变化、尿量、血清钠变化以及所有不良事件的发生率。
本拟议研究的结果将总结托伐普坦治疗CHF的现有证据。
本系统评价中使用的所有数据将从先前发表的试验中收集。因此，本研究无需获得研究伦理批准。本研究结果将发表在同行评审期刊上。
PROSPERO注册号：PROSPERO CRD42019120818。
