In-hospital results of therapy with the NGLT-2 inhibitor dapagliflozin in patients with acute decompensation of heart failure: prospective randomized study

BACKGROUND: This study focuses on the development of new approaches to the management of patients with acute decompensation of heart failure (ADHF) using sodium-glucose cotransporter type 2 (iHLT-2) inhibitors, particularly dapagliflozin, and its role in early treatment initiation.

AIM: Our aim was to determine the predictors of severe ADHF outcomes in patients with low left ventricular ejection fraction (LVEF) and the role of early initiation of iGLT-2 therapy (within the first 24 h).

MATERIALS AND METHODS: This prospective randomized study included a total of 140 patients hospitalized with ADHF between January 1 to September 1, 2023. The patients were randomized into two groups: in group 1, iGLT-2 therapy was started within 24 h from the moment of admission (n=70), and in group 2, standard therapy was implemented (n=70). Hospital data were analyzed. The endpoint was the persistence of congestion in one or both circulatory circuits with New York Heart Association Functional Classes III–IV, indicating severe ADHF.

RESULTS: The initial demographic and clinical characteristics of both groups were comparable. In both groups <47% patients did not receive optimal drug therapy (excluding iGLT-2) for chronic heart failure, and no differences were found in this indicator (p=0.081). iGLT-2 therapy did not demonstrate a significant effect on the likelihood of an adverse ADHF outcome (odds ratio [OR]=0.88; 95% confidence interval [CI] 0.43–1.78, p=0.719). Multivariate analysis showed an increase in the probability of this outcome for every 1000 pg/mL increase in N-terminal propeptide of brain natriuretic hormone (NT-proBNP) (OR=1.72, 95% CI 1.37–2.17; p <0.001), blood urea per 1 mmol/L (OR=1.54, 95% CI 1.21–1.97; p=0.001), pulmonary hypertension (OR=7.08, 95% CI 2.15–23.34; p=0.001), and a decrease in the probability of outcome with a 1% increase in LVEF (OR=0.91, 95% CI 0.84–0.99; p=0.031). The sensitivity and specificity of the adverse outcome model were 91.3 and 85.1%, respectively.

CONCLUSION: The leading predictors of an unfavorable ADHF outcome include increased levels of NT-proBNP and blood urea, pulmonary hypertension, and decreased LVEF.