The EMPA-AHF trial is a multicentre, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of early initiation of once-daily oral empagliflozin 10 mg in patients hospitalized for patients with acute heart failure (AHF) who are at a high risk of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
444
once-daily oral empagliflozin 10 mg
Placebo matching empagliflozin 10 mg
A hierarchical composite endpoint consisting of death within 90 days, heart failure rehospitalization within 90 days, WHF during hospitalization, and urine output up to 48 hours after treatment initiation, assessed by the win ratio
WHF, worsening heart failure
Time frame: Up to 90 days
A hierarchical composite endpoint consisting of death within 90 days, heart failure readmission within 90 days, and WHF during hospitalization
WHF, worsening heart failure
Time frame: Up to 90 days
A composite endpoint consisting of WHF during hospitalization, death, heart failure rehospitalization, urgent visit for WHF, intensification of diuretic therapy, and worsening NYHA class within 90 days
WHF, worsening heart failure
Time frame: Up to 90 days
Change in NT-proBNP from randomization to 48 hours
Time frame: Evaluated at 48 hours after randomization
Diuretic response, calculated as urine output achieved by loop diuretics (40 mg intravenous furosemide-equivalent dose) at 48 h after treatment initiation
Time frame: Evaluated at 48 hours after randomization
Improvement in KCCQ-TSS of ≥5 points from randomization to 30 and 90 days after treatment initiation
KCCQ-TSS, Kansas City Cardiomyopathy Questionnaire - Total Symptom Score. The scores range from 0 to 100, with 100 being the best possible score.
Time frame: Up to 90 days
Time to hemodynamic stabilization during index hospitalization
Time frame: During index hospitalization
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Anjo Kosei Hospital
Anjo, Aichi-ken, Japan
RECRUITINGAichi Medical University Hospital
Nagakute, Aichi-ken, Japan
RECRUITINGNagoya University Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGHirosaki University Hospital
Hirosaki, Aomori, Japan
RECRUITINGHyogo Prefectural Awaji Medical Center
Sumoto, Awaji, Japan
ACTIVE_NOT_RECRUITINGFunabashi Municipal Medical Center
Funabashi, Chiba, Japan
RECRUITINGKameda Medical Center
Kamogawa, Chiba, Japan
RECRUITINGJuntendo University Urayasu Hospital
Urayasu, Chiba, Japan
RECRUITINGFukuokaken Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka, Japan
RECRUITINGJapanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, Japan
RECRUITING...and 59 more locations
Re-worsening of heart failure during index hospitalization
Time frame: During index hospitalization
Heart failure rehospitalization
Time frame: Up to 90 days
Death
Time frame: Up to 90 days
Urine output during the 48 h after randomization
Time frame: Evaluated at 48 hours after randomization
Cardiovascular death
Time frame: Up to 90 days
Change in the visual analog scale score for dyspnea from after randomization to 24 and 48 h
The scores range from 0 to 100, with 100 being the best possible score.
Time frame: Evaluated at 24 and 48 hours after randomization
Change in high sensitivity cardiac troponin T
Time frame: Evaluated at 48 hours after randomization
Change in the KCCQ-TSS after randomization to 30 and 90 days
KCCQ-TSS, Kansas City Cardiomyopathy Questionnaire - Total Symptom Score. The scores range from 0 to 100, with 100 being the best possible score.
Time frame: Up to 90 days
Composite of renal replacement therapy, renal transplantation, eGFR <15 mL/min/1.73m2, ≥50% decrease in eGFR compared to the first sample or a ≥2-fold increase in creatinine level compared to the first sample within 90 days of randomization
Time frame: Up to 90 days
Trend in eGFR after randomization to 24 h, 48 h, 30 days, and 90 days
Time frame: Up to 90 days
Days alive and out of hospital (including those for reasons other than heart failure)
Time frame: Up to 90 days