STUDY DESIGN

Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been shown to effectively treat chronic heart failure (HF) in multiple large clinical trials.¹ However, the potential clinical benefits of empagliflozin, the SGLT2 inhibitor, in patients hospitalized for acute HF are currently unclear.¹ The EMPULSE trial was designed to address this knowledge gap by recruiting 530 patients who had been hospitalized after an acute HF event (HFE).¹ The participants were randomized 1:1 to receive 10mg oral empagliflozin (n=265) or placebo (n=265) within 1-5 days of admission.¹ Notably, patients were also included regardless of ejection fraction (EF) or diabetes status.¹

All patients had met the stabilization criteria of systolic blood pressure (BP) of ≥100 mmHg and without the need for intravenous (IV) vasodilators or inotropic drugs.¹ Additionally, they had congestion as evidenced by elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) or BNP and the need for diuretic therapy but without an increase in the dose 6 hours prior to randomization.¹ Patients were followed up for 90 days with assessments conducted on days 15, 30 and 90.¹

The primary endpoint of the study was the clinical benefit at 90 days assessed using a win ratio, which is a hierarchical composite of death, number of HFEs [i.e., hospitalizations from HF (HHFs), urgent HF visits and unplanned outpatient visits], time to first HFE, and the change in quality of life (QoL) assessed by the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS).¹ The selected secondary endpoints included time to all-cause death, first HFE, KCCQ-TSS change from baseline, and body weight (kg) change from baseline after 90 days of treatment.¹

FINDINGS

"All these results concluded early initiation of empagliflozin  vs. placebo in patients hospitalized for acute HF is good and  beneficial for the patients and should be done."

^{Professor Christiane E. Angermann
Comprehensive Heart Failure Centre,
University of Würzburg,
Germany}