| Outcome Measures: |
Primary: Extracellular volume (ECV, %), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the extracellular volume (ECV) of the remote myocardium between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔECV dapagliflozin group versus ΔECV placebo group; \[ΔECV = ECV 6-month - ECV baseline\])., 6 months | Secondary: Serum levels of C-terminal propeptide of type I procollagen (PICP), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of C-terminal propeptide of type I procollagen (PICP) between the 6-month and baseline follow- up (ΔPICP dapagliflozin group versus ΔPICP placebo group; \[ΔPICP = PICP 6-month - PICP baseline\])., 6 months|N-terminal propeptide of type III (PIIINP), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of N-terminal propeptide of type III (PIIINP) between the 6-month and baseline follow- up (ΔPIIINP dapagliflozin group versus ΔPIIINP placebo group; \[ΔPIIINP = PIIINP 6-month - PIIINP baseline\])., 6 months|Galectin-3 procollagen (Gal-3), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of galectin-3 procollagen (Gal-3) between the 6-month and baseline follow- up (ΔGal-3 dapagliflozin group versus ΔGal-3 placebo group; \[ΔGal-3 = Gal-3 6-month - Gal-3 baseline\])., 6 months|High-Sensitivity cardiac Troponin I (hs-cTnI), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of High-Sensitivity cardiac Troponin I (hs-cTnI) between the 6-month and baseline follow- up (hs-cTnI dapagliflozin group versus hs-cTnI placebo group; \[Δhs-cTnI = hs-cTnI 6-month - hs-cTnI baseline\])., 6 months | Other: N-terminal pro-brain natriuretic peptide (NT-proBNP), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) between the 6-month and baseline follow- up (NT-proBNP dapagliflozin group versus NT-proBNP placebo group; \[ΔNT-proBNP = NT-proBNP 6-month - NT-proBNP baseline\])., 6 months|Soluble suppression of tumorigenicity 2 (sST2), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of Soluble suppression of tumorigenicity 2 (sST2) between the 6-month and baseline follow- up (sST2 dapagliflozin group versus sST2 placebo group; \[ΔsST2 = sST2 6-month - sST2 baseline\])., 6 months|Indexed ventricular mass of the left ventricle (LVMI, g/m^2), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Indexed ventricular mass of the left ventricle (LVMI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVMI dapagliflozin group versus ΔLVMI placebo group; \[ΔLVMI = LVMI 6-month - LVMI baseline\])., 6 months|Indexed End-diastolic volume of the left ventricle (LVEDVI, mL/m^2), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Indexed End-diastolic volume of the left ventricle (LVEDVI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVEDVI dapagliflozin group versus ΔLVEDVI placebo group; \[ΔLVEDVI = LVEDVI 6-month - LVEDVI baseline\])., 6 months|Indexed End-systolic volume of the left ventricle (LVESVI, mL/m^2), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Indexed End-systolic volume of the left ventricle (LVESVI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVESVI dapagliflozin group versus ΔLVESVI placebo group; \[ΔLVESVI = LVESVI 6-month - LVESVI baseline\])., 6 months|Left ventricular ejection fraction (LVEF, %), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Left ventricular ejection fraction (LVEF) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVEF dapagliflozin group versus ΔLVEF placebo group; \[ΔLVEF = LVEF 6-month - LVEF baseline\])., 6 months|Body weight (BW, Kgs), To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Body weight (BW) between the 6-month and baseline follow- up, (ΔBW dapagliflozin group versus ΔBW placebo group; \[ΔBW = BW 6-month - BW baseline\])., 6 months|Major Adverse Cardiovascular Events (MACE), Difference in the incidence of Major Adverse Cardiovascular Events (MACE), defined as a composite of death, non-fatal myocardial infarction, and non-fatal stroke, between the dapagliflozin and placebo groups., 6 months|Hospitalizations for Heart Failure (HHF), Difference in the incidence of Hospitalizations for Heart Failure (HHF) between the dapagliflozin and placebo groups., 6 months
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| Locations: |
Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, 08025, Spain|Hospital Clinic of Barcelona, Barcelona, Catalonia, 08036, Spain
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