- Question
- To determine whether empagliflozin, an SGLT2 inhibitor with proven benefit in heart failure with reduced ejection fraction, improves clinical outcomes in patients with heart failure and a preserved ejection fraction.
- Design
- Randomized, double-blind, placebo-controlled phase III trial enrolling 5988 patients, with a median follow-up of 26.2 months.
- Population
- Patients with chronic heart failure in NYHA class II-IV and an ejection fraction above 40%, with or without diabetes.
- Intervention
- Empagliflozin 10 mg once daily on top of usual therapy.
- Control
- Once-daily placebo on top of usual therapy.
- Primary outcome
- Composite of cardiovascular death or hospitalization for heart failure, analyzed as time to first event.
- Results
- The primary outcome occurred in 415 of 2997 patients (13.8%) with empagliflozin and 511 of 2991 (17.1%) with placebo (HR 0.79; 95% CI 0.69 to 0.90; P<0.001), driven mainly by a lower risk of heart failure hospitalization. Total heart failure hospitalizations were lower with empagliflozin (407 vs. 541; HR 0.73; 95% CI 0.61 to 0.88; P<0.001).
- Safety
- Uncomplicated genital and urinary tract infections and hypotension were reported more often with empagliflozin.
- Conclusion
- Empagliflozin reduced the combined risk of cardiovascular death or heart failure hospitalization in patients with preserved ejection fraction, regardless of diabetes status.
- Why it matters
- It was among the first trials to show a clinical benefit of a drug in heart failure with preserved ejection fraction, a condition with few effective treatment options, and extended the role of SGLT2 inhibitors across the whole ejection fraction spectrum.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026