Effect of sacubitril/valsartan on sinus rhythm maintenance after catheter ablation in patients with persistent atrial fibrillation without reduced ejection fraction heart failure: a study protocol for a multi-center, open-label, randomized, controlled, superiority clinical trial.

Introduction: A high recurrence rate of atrial fibrillation was monitored after catheter ablation for persistent atrial fibrillation. Sacubitril/valsartan can improve outcomes for patients with heart failure and ventricular tachycardia, but few studies examined whether it can reduce recurrence or improve cardiovascular outcomes in patients with persistent atrial fibrillation after catheter ablation. In this study, we will assess the effect of sacubitril/valsartan on sinus rhythm maintenance and incidence of major adverse cardiovascular events (MACE) in patients with persistent atrial fibrillation after catheter ablation through a randomized controlled trial (RCT). Methods: This is a multi-center, randomized, controlled, open-label, superiority clinical trial involving 462 patients without reduced ejection fraction heart failure after catheter ablation of persistent atrial fibrillation. Patients will be randomized to (1) receive the standard treatment strategy plus sacubitril/valsartan titration, or (2) receive the standard treatment strategy without taking sacubitril/valsartan. The primary outcome will be sinus rhythm maintenance rate over 12 months, monitored by random electrocardiogram and 24-h Holter electrocardiogram. Discussion: This study is designed to evaluate the effect of sacubitril/valsartan on sinus rhythm maintenance and incidence of major adverse cardiovascular events (MACE) in patients with persistent atrial fibrillation after catheter ablation. The results will evaluate sacubitril/valsartan as a novel treatment for improving prognosis and a complement to conventional drug therapy. Trial Registration: Registered with Chinese Clinical Trials Registry on 27 August 2022, identifier: ChiCTR2200062995.

Abnormal adiposity indices are associated with an increased risk of diabetes in a non-obese Asian population.

OBJECTIVES: The aim of this study was to evaluate the association between adiposity indices and the risk of incident diabetes and to compare their predictive ability in non-obese healthy individuals. STUDY DESIGN: Population-based cohort study. METHODS: Data were taken from the NAGALA research study, which enrolled Japanese adults aged 18-79 years. Cox regression was used to evaluate the association between adiposity indices (including waist circumference [WC], waist-to-height ratio [WHtR], lipid accumulation product index [LAP], body roundness index [BRI], visceral adiposity index [VAI] and Chinese visceral adiposity index [CVAI]) and diabetes risk. The performance of the indices for predicting diabetes was explored using area under the receiver operating characteristic curve (AUC). A Chinese community-based population was used for validation. RESULTS: A total of 12,940 healthy Japanese individuals with normal body mass index and glycaemic levels were included and were followed up for a median of 6 years. Multivariable Cox models revealed a positive and significant association between all indices and incident diabetes, with the hazard ratios for the highest quartile of the indices ranging from 1.89 to 2.90 (all P-values < 0.01). A non-linear association between WC, BRI and VAI and a linear association between WHtR, LAP and CVAI and diabetes risk were observed. CVAI, VAI and LAP had comparable ability in predicting diabetes, with the highest AUC being 0.733 for CVAI. Data from 10,830 Chinese individuals confirmed these results. CONCLUSIONS: Adiposity indices are associated with incident diabetes in healthy non-obese individuals. Participants in the highest quartile of WC, WHtR, LAP, BRI, VAI and CVAI had an increased risk of developing diabetes.

Effect of probiotic supplementation on in-hospital mortality in patients with acute myocardial infarction: a study protocol for an open-label, randomized, controlled, superiority clinical trial.

BACKGROUND: Recent studies have demonstrated a correlation between intestinal flora and the severity of myocardial infarction as well as post-myocardial infarction repair. However, few studies have investigated whether probiotics reduce mortality and improve cardiovascular outcomes in patients with acute myocardial infarction. In this study, we will conduct a randomized controlled trial (RCT) to evaluate the effect of probiotics on in-hospital mortality and the incidence of major adverse cardiovascular events (MACE) in patients with acute myocardial infarction (AMI). METHODS: This is an open-label, randomized, controlled, superiority clinical trial involving 2594 adult patients who were diagnosed with acute myocardial infarction. Patients will be randomized to (1) receive bifidobacteria triple viable capsule (Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis) 840 mg, twice a day, plus standard treatment strategy during the hospital stay, for a maximum of 30 days, or (2) receive the standard treatment strategy and will not take the bifidobacterium triple live capsule. The primary outcome was in-hospital all-cause mortality. DISCUSSION: The purpose of this clinical trial is to determine whether probiotics can reduce in-hospital mortality and improve prognosis in patients with AMI, and the results will provide evidence for probiotics as a complementary treatment for AMI. TRIAL REGISTRATION: Chinese Clinical Trials Registry ChiCTR2000038797. Registered on 2 October 2020.

Clinical effects and safety of edaravone in treatment of acute ischaemic stroke: A meta-analysis of randomized controlled trials.

WHAT IS KNOWN AND OBJECTIVE: Edaravone is a new antioxidant and hydroxyl radical scavenger. Although there is evidence that it improves clinical outcomes of patients with acute ischaemic stroke (AIS), it is not yet widely accepted for treatment of AIS in Western countries. We further investigated the efficacy and safety of edaravone through this meta-analysis of randomized controlled clinical trials (RCTs). METHOD: Pubmed, Embase, Web of Science and Cochrane Library were screened up to December 2020 for original articles from SCI journals that published in English. RCTs that compared edaravone versus placebo or no intervention in adult patients and reported the efficacy or safety of edaravone were regarded as eligible. Mortality was regarded as the primary outcome and the improvement of neurological impairment was regarded as the secondary outcome. Safety evaluation was conducted according to the incidence of adverse events. Review Manager 5.3 was employed to perform the assessment of the risk of bias and data synthesis. The Cochrane risk of bias tool for randomized controlled trials was employed to assess the risk of bias. RESULTS AND DISCUSSION: Seven randomized controlled trials with 2069 patients were included. For the incidence of mortality, the pooled RR for studies that evaluated edaravone after three-month follow-up was 0.55 (95% Cl, 0.43-0.7, I2  = 0, P < 0.01). The pooled RR for improvement of neurological impairment at the three months follow-up was 1.54 (95% CI, 1.27-1.87, I2  = 0, P < 0.01) in four RCTs. On subgroup analysis of studies that were conducted in Asia, the RR was 1.56 (95% CI, 1.27-1.90, I2  = 0%; P < 0.01); the pooled RR for studies that conducted in Europe was 1.32 (95% CI, 0.64-2.72; P = 0.45); the pooled RR for studies that used edaravone for two weeks was 1.42 (95% CI, 1.10 to 1.83, I2  = 0%; P < 0.01); the pooled RR for studies that used edaravone for one week was 1.64 (95% CI, 1.24-2.16, I2  = 0%; P < 0.01); the pooled RR for studies that conducted in patients with mean age equal to or over 60 years was 1.52 (95% CI, 1.24-1.87, I2  = 0%; P < 0.01); and the pooled RR for studies that conducted in patients with mean age less than 60 was 1.80 (95% CI, 1.05-3.08, I2  = 0%; P = 0.03). For the incidence of any treatment-related adverse events, the pooled RR for studies that evaluated edaravone during treatment was 0.83 (95% CI, 0.51-1.34, I2  = 0, P = 0.43). The difference of the incidence of any treatment-related adverse events between two groups was not statistically significant. WHAT IS NEW AND CONCLUSION: The limited studies indicate that edaravone can improve neurological impairment with a survival benefit at three-month follow-up, regardless of the mean age and course of treatment. It is worthy of promotion in the clinical treatment of AIS in Asian countries. More well-designed RCTs with larger sample sizes are needed to determine the benefits of edaravone in patients from Western countries.