Outcomes of spironolactone treatment in patients in Northeast China suffering from heart failure with mid-range ejection fraction.

AIM: The treatment effects of spironolactone on heart failure with reduced (HFrEF LVEF <40%) and preserved (HFpEF LVEF ≥50%) ejection fraction are well characterized. It is not clear whether heart failure patients with mid-range ejection fraction (HFmrEF, LVEF 40-49%) benefit from spironolactone. The present study aims to evaluate the efficacy of spironolactone in HFmrEF patients.

METHOD: This study compared a high dosage of spironolactone (50 mg daily), a low dosage of spironolactone (25 mg daily), and an untreated group for the prevention of major adverse cardiovascular events (MACE) in 279 patients admitted to hospital diagnosed with HFmrEF.

RESULTS: With a mean follow-up duration of 1 year, the death and HF-rehospitalization rate demonstrated significantly lower incidence in those taking spironolactone, compared with the untreated group (21.3% vs 34.5%, p = .014, respectively). Further analysis showed no difference between two spironolactone groups (21.8% vs 20.7%, p = .861). Kaplan-Meier analysis of outcome-free survival illustrated a significant difference in survival rate among three groups (log-rank testing, p = .045). Compared with the baseline level, patients receiving 25 mg spironolactone had a lower physical score (p < .05) at 1-year follow-up. MLHFQ total scores in the two spironolactone groups markedly improved compared with the untreated group (p < .001); similar results were observed in the MLHFQ physical scores (p = .025, .001, respectively) and emotional sub-scale (p = .023, .011, respectively); however, paired comparison between the two spironolactone groups showed no difference.

CONCLUSIONS: In patients with HFmrEF, treatment with spironolactone significantly reduced the incidence of the primary composite outcomes of all-cause death, and rehospitalization for the management of heart failure compared with placebo, and a high dosage of spironolactone did not show trends of reduction in MACE.