The study is a short to mid-term randomized single-blind placebo controlled study that aimed to detect the effects of empagliflozin (a sodium-glucose cotransporter-2 inhibitor) compared to placebo on LV end-diastolic and end-systolic volumes, LV ejection fraction, N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity and quality of life (QoL) among non-diabetic patients with HFrEF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
Empagliflozin (a sodium-glucose cotransporter-2 inhibitor) 10 mg one tablet daily dose for 6 months
Sugar pills one tablet daily for 6 months
Beni-Suef University
BeniSuef, Egypt
The changes in LV volumes (mL)
To measure the changes in of Left Ventricular end-diastolic volume (LVEDV) (mL) and Left Ventricular end-systolic volume (LVESV) (mL) via transthoracic echocardiography using the modified Simpson's rule (the biplane disk summation approach). Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.
Time frame: From enrollment to the end of treatment at 6 months
The changes in of Left Ventricular Ejection Fraction (LVEF) (%)
To measure the changes in of Left Ventricular Ejection Fraction (LVEF) (%) via transthoracic echocardiography using the modified Simpson's rule (the biplane disk summation approach). Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.
Time frame: From enrollment to the end of treatment at 6 months
The changes in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL)
Measurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL) at baseline and at the end of treatment phase after 6 months within both study arms via the electrochemiluminescence immunoassay "ECLIA". Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.
Time frame: From enrollment to the end of treatment at 6 months
The changes in 6 minute walk test (meters)
Measurement of 6 minute walk test (meters) at baseline and at the end of treatment phase after 6 months within both study arms. Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.
Time frame: From enrollment to the end of treatment at 6 months
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The changes in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points)
Measurement of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points) at baseline and at the end of treatment phase after 6 months within both study arms. Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.
Time frame: From enrollment to the end of treatment at 6 months