Empagliflozin for New On-set Heart Failure Study Regardless of Ejection Fraction
Status:
Recruiting
Trial end date:
2024-05-31
Target enrollment:
Participant gender:
Summary
Heart failure (HF) is one of the most important reasons for hospital admission and is
associated with high mortality and morbidity. After discharge, up to 40% of patients are
readmitted within 6 months and 1-year post-discharge mortality is high. The cost burden of
treating patients with HF is high and ~80% of healthcare costs are related to hospital
admissions.
Sodium-glucose cotransporter-2 (SGLT2) inhibitor is considered one of the four foundational
therapies (ACE-I or ARNI, beta-blockers, MRA, and SGLT2 inhibitors) for HFrEF. In particular,
empagliflozin has been shown in randomized controlled trials to reduce the combined risk of
cardiovascular death or HF hospitalization in HF patients with both reduced ejection fraction
(HFrEF) and preserved ejection fraction (HFpEF). However, guidelines do not specify the
sequence and the timing of which therapy to be commenced. The timing of SGLT inhibitors
initiation in the treatment of acute HF is not established. In particular, new-onset acute HF
is a group which is understudied in the major trials to date. This study aims to evaluate the
efficacy and safety of in-hospital initiation of empagliflozin in patients hospitalized for
new onset acute HF, regardless of LVEF for up to 90 days of follow-up.