Background: 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).
Methods: 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.
Results: 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.
Conclusion: The findings of this proposed study will summarize the current evidence of tolvaptan for CHF.
Ethics and dissemination: 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 registration number: PROSPERO CRD42019120818.