The EMPULSE trial is designed to evaluate the clinical benefit and safety of in-hospital initiation of empagliflozin compared with placebo in approximately 500 patients hospitalized for acute HF.
RCT (n=500)
Double-blind
1:1
Yes
Does empagliflozin improve clinical outcomes (composite of all-cause death, HF events, and KCCQ-TSS change) in patients hospitalized for acute decompensated heart failure?
The EMPULSE trial is designed to evaluate the clinical benefit and safety of in-hospital initiation of empagliflozin in patients with acute decompensated heart failure.
AIMS: Treatment with sodium-glucose co-transporter 2 (SGLT2) inhibitors improves outcomes in patients with chronic heart failure (HF) with reduced ejection fraction. There is limited experience with the in-hospital initiation of SGLT2 inhibitors in patients with acute HF (AHF) with or without diabetes. EMPULSE is designed to assess the clinical benefit and safety of the SGLT2 inhibitor empagliflozin compared with placebo in patients hospitalized with AHF. METHODS: EMPULSE is a randomized, double-blind, parallel-group, placebo-controlled multinational trial comparing the in-hospital initiation of empagliflozin (10 mg once daily) with placebo. Approximately 500 patients admitted for AHF with dyspnoea, signs of fluid overload, and elevated natriuretic peptides will be randomized 1:1 stratified to HF status (de-novo and decompensated chronic HF) to either empagliflozin or placebo at approximately 165 sites across North America, Europe and Asia. Patients will be enrolled regardless of ejection fraction and diabetes status and will be randomized during hospitalization and after stabilization (between 24 h and 5 days after admission), with treatment continued up to 90 days after initiation. The primary outcome is clinical benefit at 90 days, consisting of a composite of all-cause death, HF events, and ≥5 point change from baseline in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS), assessed using a 'win-ratio' approach. Secondary outcomes include assessments of safety, change in KCCQ-TSS from baseline to 90 days and change in natriuretic peptides from baseline to 30 days. CONCLUSION: The EMPULSE trial will evaluate the clinical benefit and safety of empagliflozin in patients hospitalized for AHF.
Tromp et al. (Sat,) conducted a rct in Acute decompensated heart failure (n=500). Empagliflozin vs. Placebo was evaluated on Clinical benefit at 90 days (composite of all-cause death, HF events, and ≥5 point change from baseline in KCCQ-TSS assessed using a win-ratio approach). The EMPULSE trial is designed to evaluate the clinical benefit and safety of in-hospital initiation of empagliflozin compared with placebo in approximately 500 patients hospitalized for acute HF.