Empagliflozin in heart failure with preserved ejection fraction: from randomized trials to real-world evidence

Abstract

Background : The EMPEROR-Preserved clinical trial established empagliflozin as an effective therapy in heart failure with preserved ejection fraction (HFpEF), yet real-world validation in elderly, comorbid populations remain limited. We aimed to evaluate the clinical profile, tolerability, and outcomes of empagliflozin in a large Belgian HFpEF cohort. Methods : This retrospective, single-centre observational study of consecutive HFpEF patients (LVEF >50%) initiated on empagliflozin (10 mg daily) between April 2023 and April 2024. Baseline characteristics, clinical parameters, laboratory values, and outcomes were collected from electronic health records. Results : Of 798 screened patients, 577 were included (median age 82 years, 58% female). Atrial fibrillation (67%) and hypertension (78%) were highly prevalent. Empagliflozin use was associated with significant improvements in NYHA functional class (NYHA II: 56% to 77%, p < 0.001) and reduction in peripheral oedema (26% to 9%, p < 0.001). Modest reductions were observed in systolic blood pressure (131 to 130 mmHg, p = 0.017), heart rate (71 to 68 bpm, p = 0.004), body weight (76 to 75 kg, p < 0.001), and BMI (27.7 to 27.2 kg/m2, p < 0.001). Haemoglobin levels increased (p = 0.002), while renal function declined modestly without clinical sequelae. Treatment discontinuation occurred in 2.8% of patients, mainly due to genitourinary infections. During a median follow-up period of 16 months, the all-cause mortality rate was 6.9%. Conclusion : In real-world elderly and comorbid HFpEF population, empagliflozin was well tolerated and associated with improvements in congestion and functional status, supporting the external validity of randomised trial findings.