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

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.

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.

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%.

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.