Clinical outcomes and safety of finerenone in patients with heart failure: a real-world observational study in China

Objective Finerenone is a highly selective nonsteroidal mineralocorticoid receptor antagonist, but data on its benefits in the treatment of heart failure (HF) in real-world clinical practice remain insufficient. This study investigated the benefits and outcomes of finerenone in patients with HF using a single-center, real-world study design. Methods This single-center, retrospective observational study included consecutive patients diagnosed with HF and treated with add-on finerenone between August 2023 and May 2024 at Tongji Hospital, Shanghai, China. All patients received finerenone add-on to standard treatment. Subgroup analyses were performed in patients with HF with preserved ejection fraction (HFpEF), HF with mildly reduced ejection fraction (HFmrEF), and HF with reduced ejection fraction (HFrEF). Adverse events were recorded, including HF readmission, outpatient visits for acute HF, and diuretic dosage escalation. Laboratory and cardiac function markers were also collected. Results Seventy-three patients were included. Left atrial diameter decreased from 50 mm to 49 mm at 6 months and further decreased to 48 mm at 12 months (P < 0.001). The E/e’ ratio decreased from a median value of 10.65 to 9.20 at 6 months and to 8.20 at 12 months (P < 0.001). The median NT-proBNP decreased from 3 months of treatment (30.41%) and continued to decline, with a 67.47% decrease at 12 months (P < 0.001). New York Heart Association (NYHA) improved from baseline (Class II: 58.9%; Class III: 41.1%) to 12 months (Class I: 5.5%; Class II: 94.5%) (P < 0.001). These changes were consistent among the HFrEF, HFmrEF, and HFpEF subgroups. LVEF improved by a median of 2% at 6 months and 3% at 12 months (P < 0.001). No patients discontinued finerenone due to adverse events, suggesting that the drug was well tolerated in real-world patients with HF. Eight (11.0%) patients were re-admitted due to HF, and seven (9.6%) required an increase in diuretic dosage during follow-up. Conclusion In real-world clinical practice, finerenone exhibited a good clinical and safety profile in patients with HF, with profiles similar across the HFrEF, HFmrEF, and HFpEF subgroups. Future larger-sample, multicenter randomized controlled trials are needed to confirm those benefits.