Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), increases natriuresis alone and synergistically when combined with loop diuretics in patients with AHF without increasing renin angiotensin- aldosterone activity. Thus, adding SGLT2i to the standard loop diuretic therapy might confer additional decongestive and natriuretic benefits while avoiding the adverse electrolyte abnormalities and neurohormonal activation associated with other diuretic combination. These potential benefits may help with improved clinical outcomes, but clinical evidence is still lacking.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
87
patients will receive once daily dapagliflozin 10 mg orally in addition to standard care
patients will receive placebo and standard care.
Noha Mansour
Al Mansurah, Egypt
Change in dyspnea ( Visual analogue scale) (VAS)
• Comparing the area under the curve (AUC) of change in VAS dyspnea score. To do so, individual changes in VAS score will be visualized as a curve where the x-axis shows study day baseline to day 5, and y-axis shows VAS score. the overall VAS AUC score (mm × h) will be compared across treatment groups
Time frame: From baseline to day 4
Incidence of worsening heart failure (HF)
Defined as worsening signs and/or symptoms of HF that require IV inotropic therapy or admission to an intensive care unit or mechanical ventilatory, renal or circulatory support.
Time frame: From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days
All-cause death
Difference in all cause mortality rate
Time frame: 30 days from discharge
All-cause death
Difference in all cause mortality rate
Time frame: 60 days from discharge
Hospital readmission
Difference between groups in rate of readmission after discharge for heart failure related reason
Time frame: 30 days from discharge
Hospital readmission
Difference between groups in rate of readmission after discharge for heart failure reason
Time frame: 60 days from discharge
Urinary sodium 2 hours post randomization
Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups
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Time frame: 2 Hours
Difference in serum levels of congestion biomarkers
Difference in serum levels of Nt-ProBNP 4 days post-randomization
Time frame: 4 days post-randomization