Although empagliflozin has been recommended for individuals with heart failure, its effects on heart failure with preserved ejection fraction (HFpEF) remain uncertain from a physiopathological standpoint. The metabolites produced by gut microbiota have been shown to have a crucial role in the development of heart failure. Sodium-glucose cotransporter-2 inhibitors (SGLT2) have been shown to change the make-up of the gut microbiota in rodent studies. There is mixed evidence from similar studies investigating whether or not SGLT2 can affect the microbiota in the human gut. This trial is a pragmatic, randomized, open-label controlled study with empagliflozin as an intervention. We will enroll 100 patients with HFpEF and randomly assign them to one of two groups to receive either empagliflozin or a placebo. Patients in the Empagliflozin group will be given 10 mg of the drug daily, while those in the Control group will not be given empagliflozin or any other SGLT2. The purpose of the trial is to validate the changes that occur in gut microbiota in patients with HFpEF who take empagliflozin and to investigate the function of gut microbiota and their metabolites in the process.
Aim: To develop and validate internally a multivariate risk model for predicting the in-hospital mortality of patients with heart failure with preserved ejection fraction (HFpEF) and heart failure with mid-range ejection fraction (HFmrEF). Methods & results: The clinical data of 8172 inpatients with HFpEF and HFmrEF was used to establish a retrospective database. These patients, among whom 307 in-hospital deaths (3.8%) occurred, were randomly assigned to derivation and verification cohort. Among the extracted data from the derivation cohort were nine variables significantly related to in-hospital mortality, which were scored 0–4, for a total score of 24, which allowed formation of a risk predictive model. The verification cohort was then used to validate the discrimination and calibration capacities of this predictive model: the area under curve equaled 0.8575 (0.8285, 0.8865) for the derivation cohort, and 0.8323 (0.7999, 0.8646) for the verification cohort. According to this risk score, we divided patients into four risk classes (low-, medium-, high- and extremely high-risk) and revealed that the risk of in-hospital mortality increased with increasing risk class with an obvious linear relationship between actual and predicted mortality (r = 0.998, p < 0.001). Conclusion: The model based on nine common clinical variables should provide an accurate prediction of in-hospital mortality and appears to be a reliable risk classification system for patients with HFpEF and HFmrEF.
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