A Phase 3, Randomized, Double-blind, Placebo-controlled Study to evaluate Efficacy and Safety of Empagliflozin in the prevention of Cardiotoxicity in Cancer patients undergoing Chemotherapy based on Anthracyclines (EMPACT study)

Cardiotoxicity. The study population will consist of patients diagnosed with cancer, scheduled for high dose anthracyclines (doxorubicin ≥240 mg/m2 or epirubicin ≥360 mg/m2) as standard of care (SoC) systemic anticancer treatment., without history of heart failure and LV ejection fraction (EF) ≥ 50%

Time to first event of left ventricular systolic dysfunction. Criterion for the diagnosis of left ventricular systolic dysfunction in echocardiography: reduction of left ventricular ejection fraction (LVEF)> 10 percentage points from baseline to <50%

Overall response rate 1. Composite secondary endpoint • all-cause death • cardiovascular death • myocardial infarction • stroke 2. Other: • decrease in GLS (global longitudinal strain) • structural myocardial alterations in CMR • changes in the concentration of biomarkers in blood samples (Troponin T, NTproBNP), Incidence and intensity of Adverse events (AEs), including serious AEs (SAEs).Withdrawal from study drug due to AEs • Clinically relevant changes in laboratory assessments from baseline. • Clinically relevant new finding or worsening of existing condition on physical examination • Assessment of vital status. AESIs: ketoacidosis, lower limb amputation • Laboratory parameters: hematology, serum chemistry, lipids profile, and urinalysis.Physical Examination •Vital Status: SBP, DBP and pulse rate

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