National, multicenter, randomized, double-blind, parallel-group, stratified by SGLT-2 inhibitor type, placebo-controlled trial, - a Phase III study. Primary objective of the study is to investigate the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on clinical endpoints in patients hospitalized with acute/decompensated HF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,364
Autonomous Public Specialist Western John Paul II Hospital
Grodzisk Mazowiecki, Poland
RECRUITINGTime to first event of adjudicated cardiovascular (CV) death, or adjudicated hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF)
combined endpoint
Time frame: at 3 and 9 months
Difference in the number of recurrent hospitalizations due to heart failure between the treatment groups
recurrent hospitalizations due to heart failure
Time frame: at 3 and 9 months
Difference in the number of hospitalizations for CV causes between the treatment groups
hospitalizations for CV causes
Time frame: at 3 and 9 months
Difference in the number of hospitalizations for other than CV causes between the treatment groups
hospitalizations for other than CV causes
Time frame: at 3 and 9 months
Time to adjudicated CV death
CV death
Time frame: at 3 and 9 months
Time to adjudicated all cause death
all cause death
Time frame: at 3 and 9 months
Time to adjudicated myocardial infarction
myocardial infarction
Time frame: at 3 and 9 months
eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation)) creatine slope of change from baseline between the treatment groups
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eGFR
Time frame: at 3 and 9 months
Difference in the number of hospital re-admissions due to heart failure between the treatment groups
hospital re-admissions due to heart failure
Time frame: at 3 and 9 months
Difference in the number of hospital re-admissions for any cause between the treatment groups
hospital re-admissions for any cause
Time frame: at 3 and 9 months
Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment
duration of hospital stay
Time frame: at 3 and 9 months
Difference in the number of incidences of new onset AF and re-occurrence of AF between treatment groups
new onset AF
Time frame: at 3 and 9 months
Difference in the change of ejection fraction in echocardiography between treatment groups
ejection fraction
Time frame: at 3 and 9 months
Difference in the change of left ventricular diastolic function in echocardiography
left ventricular diastolic function
Time frame: at 3 and 9 months
Difference in the change of LV strain analysis in echocardiography
LV strain
Time frame: at 3 and 9 months
The time-averaged proportional change in NT-proBNP from
NT-proBNP
Time frame: at 3 and 9 months
The time-averaged proportional change in selected miRNA expression linked to hypertrophy, inflammation, fibrosis, apoptosis, electric stability between treatment groups and placebo group
miRNA expression
Time frame: at 3 and 9 months
The time-averaged proportional change in pre-specified biomarkers
biomarkers
Time frame: at 3 and 9 months
Change from baseline in clinical summary score (HF (Chronic Heart Failure) symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
HF score
Time frame: at 3 and 9 months