INTRODUCTION: Sex differences are reported in patients with heart failure (HF), but gaps remain in clinical practice and evidence, in particular, in those with advanced HF. METHODS: The HELP-HF registry enrolled consecutive patients with HF and at least one high-risk 'I NEED HELP' marker, evaluated at four Italian centres between 1 January 2020 and 30 November 2021. Patients' characteristics and outcomes were compared in men vs women. The primary endpoint was the composite of all-cause mortality or first HF hospitalization. RESULTS: A total of 1149 patients were included (mean age 75.1 ± 11.5 years, median left ventricular ejection fraction 35%). Among them, 773 patients (67.3%) were males. Males were younger, had more cardiovascular diseases and a lower left ventricular ejection fraction (32%, [interquartile range 25-45] vs 45% [interquartile range 30-55]), while females showed a higher prevalence of non-cardiac conditions, neurocognitive and depressive disorders. The 1-year rate of the primary composite endpoint was 43.2% in males and 43.1% in females (log-rank P = .857). Multivariable analysis confirmed the lack of a significant impact of sex on the primary endpoint (adjusted hazard ratio 1.03, 95% confidence interval 0.85-1.27, P = .740). No significant differences were also observed in men vs women for the individual endpoints. CONCLUSIONS: In our registry enrolling patients with markers of advanced HF, despite differences in clinical and echocardiographic characteristics, no sex-related differences in clinical outcomes were observed.
