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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
This is an investigator-initiated, prospective, single-centre, non-randomized open label study that evaluates the efficacy and safety of initiating empagliflozin during index hospitalization for acute heart failure regardless of LVEF.
The Chinese University of Hong Kong
Shatin, Hong Kong
RECRUITINGHeart failure (HF) events
Number of heart failure events (including hospitalization for HFs, urgent heart failure visits and unplanned outpatient visits), time to first heart failure event.
Time frame: 90 days
All-cause mortality
All-cause mortality after 90 days of treatment
Time frame: 90 days
Change in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)
Change from baseline in KCCQ-TSS. Scores are transformed to a range of 0-100, where higher scores reflect better health status.
Time frame: 90 days
NT-proBNP level
Change from baseline in log-transformed NT-proBNP level
Time frame: 90 days
New York Heart Association (NYHA) class
Change in NYHA class (I-IV), Class IV is most severe; Class I least severe
Time frame: 90 days
Major Adverse Cardiovascular Event (MACE)
Measure the occurrence of MACE, including Days alive and out of hospital, occurrence of hypertensive Heart failure from study drug initiation until 90 days after initial hospital discharge and randomization; Time to first occurrence of cardiovascular death or heart failure event until end of trial visit
Time frame: 90 days
Occurrence of kidney damage
Occurrence of chronic dialysis or renal transplant or sustained reduction of ≥40% estimated glomerular filtration rate (eGFR), or * Sustained eGFR \<15mL/min/1.73m2 for patients with baseline eGFR ≥30 mL/min/1.73m2 * Sustained eGFR \<10mL/min/1.73m2 for patients with baseline eGFR \<30 mL/min/1.73m2.
Time frame: 90 days
Weight loss
Weight loss per mean daily loop diuretic dose after 15, 30, 60 and 90 days of treatment.
Time frame: 90 days
Quality-adjusted life years (QALY) gained
Quality-adjusted life years (QALY) gained due to early initiation of empagliflozin
Time frame: 90 days
Change in 6 minute hall walk (6MHW)
Change from baseline in 6MHW result
Time frame: 90 days
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