Dapagliflozin Shows Promising Efficacy and Safety in Pediatric HFrEF: Study
A new study published in the Frontiers in Cardiovascular Medicine showed that Dapagliflozin improved key cardiac parameters in children with heart failure with reduced ejection fraction (HFrEF), including left ventricular ejection fraction (LVEF), B-type natriuretic peptide (BNP) levels, and New York Heart Association (NYHA) functional class. The treatment was well tolerated with no reported hospitalizations, deaths, or serious adverse effects. Weight-based dosing demonstrated acceptable short-term safety.
The study analyzed electronic medical records from 32 children treated with dapagliflozin from June 2021 to June 2023 at the Shanghai Children's Medical Center and Fujian Children's Hospital. Their outcomes were compared with a control group of 42 children who received standard heart failure therapy but not dapagliflozin.
All patients were treated with guideline-directed therapy, including ACE inhibitors or angiotensin receptor-neprilysin inhibitors (ARNI), beta-blockers, and aldosterone receptor antagonists. Dapagliflozin dosing was carefully adjusted based on body weight, ranging from 0.2 mg/kg/day for the smallest patients to 10 mg/day for those weighing over 30 kg.
After approximately 24 weeks of treatment, children who received dapagliflozin showed significant improvement in left ventricular ejection fraction. Levels of B-type natriuretic peptide (BNP) biomarker which is associated with heart failure severity, decreased significantly. Also, patients who experienced measurable improvements in their NYHA functional classification indicated better physical capacity and reduced symptoms.
When compared to the control group, the dapagliflozin-treated patients demonstrated greater improvement in both LVEF and NYHA classification, which suggested an added benefit beyond standard therapy. However, differences in BNP level reduction between the two groups were not statistically significant.
No hospitalizations or deaths due to worsening heart failure were reported in the dapagliflozin group during the study period. While a small number of patients experienced side effects, including 3 cases each of urinary tract infections and hypotension, no serious adverse events such as hypoglycemia or liver and kidney dysfunction were observed.
The children enrolled in the study had a range of underlying conditions, with dilated cardiomyopathy being the most common. Other causes included congenital heart disease and arrhythmias.
Overall the findings of this study suggest that dapagliflozin may be a promising adjunct therapy for pediatric heart failure, by improving cardiac function with an acceptable safety profile in the short term. Also, the weight-based dosing approach used in the study appeared appropriate for children of varying sizes. Larger, prospective clinical trials are imperative to confirm these findings and establish long-term safety.
Source:
Lin, S., Chen, Y., Zhu, D., Wu, J., Fu, L., Li, F., & Guo, X. (2026). Effect of dapagliflozin on heart failure with reduced ejection fraction in children. Frontiers in Cardiovascular Medicine, 13(1785458), 1785458. https://doi.org/10.3389/fcvm.2026.1785458
