Efficacy and safety of thyroxine therapy on patients with heart failure and subclinical hypothyroidism: A protocol for systematic review and meta-analysis

BACKGROUND: Subclinical hypothyroidism (SCH) can increase the risk of heart failure (HF) clinically. However, thyroxine therapy for patients with HF and SCH has the risk of developing tachyarrhythmias. At present, there is no sufficient evidence-based medical evidence for levothyroxine in the therapy of this situation, and the treatment issue is still controversial. Therefore, our meta-analysis aims to assess the effectiveness and safety of thyroxine therapy for patients with HF and SCH. METHODS: We searched the related randomized controlled trials that have been published in the following 7 electronic databases: PubMed, Cochrane Library, EMBASE, Chongqing VIP, China National Knowledge Infrastructure, Chinese biomedical literature database, and Wan Fang database. The treatment group was treated with routine HF therapy plus thyroxine, while the control group was treated with HF routine therapy. Main outcome measures effective rate and New York Heart Association classification; Secondary outcome measures included: left ventricular ejection fraction, quality of life score, brain natriuretic peptide / N-terminal pro brain natriuretic peptide, 6-minute walk test, and adverse events. After screening studies and extracting data, we will use Cochrane collaborative tools to evaluate the risk of bias to assess the methodological quality of the included randomized controlled trials. We will use STATA 14.0 software for data synthesis and statistical analysis. Both subgroup analysis and sensitivity analysis will be used to detect potential sources of heterogeneity. In addition, we will use sensitivity analysis to test the stability of the outcomes. If possible, we will perform a funnel chart and Eggers test evaluate publication bias. The quality of the evidence will be evaluated through the grades of recommendations assessment, development, and evaluation system. RESULTS: Our findings will be published in peer-reviewed journals. CONCLUSION: This research will provide evidence about the efficacy and safety of thyroxine in the treatment of patients with HF and SCH. Objective to provide evidence-based medicine basis for thyroxine treatment of patients with SCH and HF. REGISTRATION NUMBER: INPLASY2020100062.