Table 2.
Baseline | Day 1 | Day 3 | Month 3 | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo | Empagliflozin | p | Placebo | Empagliflozin | p | Placebo | Empagliflozin | p | Placebo | Empagliflozin | p | |
Laboratory | ||||||||||||
Glucose—mg/dL | 175 ± 52 | 181 ± 75 | 0.742 | 171 ± 48 | 152 ± 38 | 0.049 | 166 ± 52 | 146 ± 35 | 0.037 | 156 ± 52 | 151 ± 42 | 0.754 |
HbA1c—% | 7.9 ± 1.3 | 7.5 ± 0.9 | 0.228 | 7.9 ± 1.3 | 7.4 ± 0.9 | 0.722 | 7.9 ± 1.2 | 7.4 ± 0.9 | 0.690 | 7.8 ± 1.5 | 7.1 ± 0.7 | 0.595 |
Total cholesterol—mg/dL | 155 ± 39 | 169 ± 41 | 0.257 | 155 ± 37 | 174 ± 43 | 0.178 | 152 ± 40 | 168 ± 39 | 0.824 | 152 ± 42 | 185 ± 48 | 0.001 |
LDL-C—mg/dL | 95 ± 38 | 103 ± 36 | 0.522 | 94 ± 36 | 102 ± 36 | 0.915 | 93 ± 39 | 102 ± 40 | 0.477 | 89 ± 39 | 112 ± 47 | < 0.001 |
HDL-C—mg/dL | 44 ± 9 | 43 ± 9 | 0.530 | 44 ± 9 | 42 ± 10 | 0.947 | 44 ± 9 | 43 ± 9 | 0.900 | 46 ± 11 | 46 ± 10 | 0.937 |
eGFR—mL/min/1.73 m2 | 88 ± 16 | 77 ± 21 | 0.076 | 85 ± 16 | 70 ± 19 | 0.014 | 85 ± 17 | 70 ± 21 | 0.039 | 85 ± 16 | 68 ± 20 | 0.108 |
Cystatin C—mg/L | 1.0 ± 0.2 | 1.2 ± 0.4 | 0.148 | 1.0 ± 0.2 | 1.3 ± 0.4 | < 0.001 | 1.0 ± 0.2 | 1.3 ± 0.4 | 0.001 | 1.0 ± 0.2 | 1.3 ± 0.4 | < 0.001 |
NT-proBNP—pg/mL | 166 (73–238) | 239 (91–463) | 0.481 | 168 (67–252) | 192 (63–385) | 0.224 | 147 (58–226) | 173 (57–402) | 0.408 | 158 (42–262) | 133 (32–500) | 0.723 |
Aldosterone—pg/mL | 83 ± 33 | 104 ± 65 | 0.213 | 88 ± 32 | 111 ± 67 | 0.825 | 96 ± 50 | 108 ± 59 | 0.635 | 108 ± 71 | 137 ± 104 | 0.522 |
24 h urine | ||||||||||||
Urinary volume—mL/24 h | 1788 ± 756 | 1740 ± 601 | 0.829 | 1626 ± 681 | 2112 ± 837 | 0.011 | 2007 ± 913 | 2111 ± 758 | 0.429 | 1664 ± 594 | 2319 ± 873 | 0.001 |
Glucose excretion—g/24 h | 10.9 ± 22.7 | 7.3 ± 22.7 | 0.617 | 6.9 ± 14.1 | 48.4 ± 34.7 | < 0.001 | 7.5 ± 14.5 | 65.7 ± 43.3 | < 0.001 | 10.2 ± 18.7 | 67.6 ± 50.9 | < 0.001 |
Sodium excretion—mmol/24 h | 196 ± 84 | 164 ± 88 | 0.255 | 181 ± 76 | 185 ± 111 | 0.223 | 203 ± 107 | 181 ± 126 | 0.970 | 175 ± 55 | 201 ± 145 | 0.054 |
Electrolyte-free water clearance—mL/24 h | − 15 ± 721 | 166 ± 830 | 0.467 | − 124 ± 654 | 417 ± 802 | 0.011 | 90 ± 874 | 461 ± 551 | 0.070 | − 91 ± 597 | 380 ± 765 | 0.013 |
Body weight—kg | 94.0 ± 14.0 | 95.8 ± 17.3 | 0.724 | 94.1 ± 14.1 | 94.9 ± 17.0 | 0.044 | 94.0 ± 14.1 | 94.5 ± 17.2 | 0.007 | 93.7 ± 14.3 | 96.0 ± 19.6 | 0.059 |
Hemodynamics | ||||||||||||
CI—L/min/m2 | 3.2 ± 0.6 | 3.2 ± 0.6 | 0.682 | 3.1 ± 0.5 | 3.1 ± 0.5 | 0.771 | 3.1 ± 0.5 | 3.0 ± 0.6 | 0.293 | 3.1 ± 0.5 | 3.1 ± 0.5 | 0.303 |
SVI—mL/b/m2 | 50 ± 7 | 47 ± 7 | 0.266 | 48 ± 8 | 45 ± 8 | 0.344 | 48 ± 8 | 44 ± 8 | 0.131 | 47 ± 7 | 47 ± 7 | 0.879 |
SVRI—dyne*s*cm−5*m−2 | 1836 ± 361 | 1841 ± 379 | 0.967 | 1942 ± 355 | 1864 ± 373 | 0.411 | 1831 ± 310 | 1837 ± 376 | 0.991 | 1909 ± 428 | 1908 ± 451 | 0.795 |
HR—bpm | 66 ± 13 | 68 ± 12 | 0.665 | 65 ± 11 | 69 ± 13 | 0.122 | 66 ± 11 | 68 ± 14 | 0.717 | 66 ± 11 | 67 ± 10 | 0.393 |
Blood pressure | ||||||||||||
Systolic—mmHg | 136 ± 18 | 135 ± 16 | 0.934 | 134 ± 16 | 128 ± 16 | 0.279 | 133 ± 19 | 125 ± 16 | 0.115 | 132 ± 20 | 128 ± 15 | 0.318 |
Diastolic—mmHg | 81 ± 14 | 82 ± 13 | 0.964 | 80 ± 13 | 80 ± 11 | 0.876 | 80 ± 12 | 80 ± 9 | 0.925 | 82 ± 11 | 79 ± 11 | 0.197 |
Echocardiography | ||||||||||||
LV-EF—% | 48 ± 6.8 | 51 ± 5.0 | 0.183 | 48 ± 6.2 | 51 ± 4.6 | 0.852 | 48 ± 6.1 | 51 ± 4.7 | 0.333 | 48 ± 6.4 | 51 ± 4.4 | 0.375 |
LVEDD—mm | 50 ± 5 | 49 ± 5 | 0.365 | 50 ± 6 | 49 ± 5 | 0.864 | 49 ± 5 | 48 ± 5 | 0.449 | 50 ± 6 | 48 ± 6 | 0.994 |
LVESD—mm | 36 ± 8 | 34 ± 6 | 0.386 | 36 ± 9 | 35 ± 5 | 0.595 | 35 ± 8 | 34 ± 5 | 0.187 | 37 ± 8 | 33 ± 6 | 0.284 |
IVSd—mm | 10 ± 2 | 10 ± 1 | 0.940 | 10 ± 2 | 11 ± 2 | 0.764 | 10 ± 2 | 11 ± 2 | 0.630 | 10 ± 2 | 10 ± 1 | 0.497 |
LV mass index—g/m2 | 91 ± 21 | 86 ± 19 | 0.474 | 94 ± 24 | 87 ± 19 | 0.448 | 90 ± 21 | 84 ± 19 | 0.701 | 89 ± 23 | 84 ± 17 | 0.807 |
LA area—cm2 | 20 ± 4.2 | 20 ± 3.7 | 0.484 | 20 ± 5.3 | 18 ± 4.3 | 0.082 | 20 ± 5.7 | 19 ± 4.8 | 0.691 | 20 ± 4.1 | 18 ± 4.0 | 0.503 |
LA volume index—mL/m2 | 31 ± 11 | 28 ± 9 | 0.414 | 30 ± 13 | 26 ± 10 | 0.300 | 30 ± 13 | 28 ± 10 | 0.840 | 31 ± 12 | 26 ± 9 | 0.239 |
E—m/s | 0.78 ± 0.14 | 0.80 ± 0.20 | 0.686 | 0.80 ± 0.12 | 0.73 ± 0.20 | 0.003 | 0.78 ± 0.11 | 0.72 ± 0.18 | 0.005 | 0.78 ± 0.13 | 0.72 ± 0.21 | 0.001 |
A—m/s | 0.73 ± 0.17 | 0.82 ± 0.17 | 0.095 | 0.74 ± 0.20 | 0.81 ± 0.15 | 0.786 | 0.75 ± 0.19 | 0.80 ± 0.15 | 0.550 | 0.73 ± 0.20 | 0.83 ± 0.15 | 0.927 |
E/A | 1.18 ± 0.53 | 0.97 ± 0.22 | 0.121 | 1.20 ± 0.55 | 0.88 ± 0.20 | 0.042 | 1.16 ± 0.58 | 0.89 ± 0.23 | 0.181 | 1.21 ± 0.52 | 0.85 ± 0.23 | 0.038 |
eʹ septal—cm/s | 7.2 ± 1.7 | 7.5 ± 1.9 | 0.603 | 6.6 ± 2.0 | 7.8 ± 2.1 | 0.077 | 7.2 ± 1.6 | 7.5 ± 2.0 | 0.785 | 7.2 ± 1.6 | 7.8 ± 2.1 | 0.470 |
eʹ lateral—cm/s | 9.8 ± 2.0 | 10.4 ± 1.8 | 0.319 | 9.6 ± 2.4 | 10.1 ± 2.4 | 0.970 | 9.5 ± 1.9 | 9.8 ± 2.3 | 0.840 | 9.3 ± 2.0 | 10.4 ± 2.9 | 0.262 |
eʹ mean | 8.5 ± 1.5 | 8.9 ± 1.6 | 0.361 | 8.1 ± 1.8 | 8.9 ± 2.1 | 0.352 | 8.4 ± 1.3 | 8.7 ± 2.0 | 0.968 | 8.3 ± 1.5 | 9.1 ± 2.3 | 0.280 |
E/eʹ mean | 9.3 ± 2.2 | 9.2 ± 2.6 | 0.898 | 10.1 ± 1.4 | 8.5 ± 2.2 | 0.005 | 9.5 ± 1.5 | 8.5 ± 2.4 | 0.079 | 9.7 ± 1.9 | 8.3 ± 2.9 | 0.004 |
DT—msec | 198 ± 54 | 206 ± 45 | 0.610 | 189 ± 45 | 212 ± 35 | 0.234 | 202 ± 54 | 215 ± 43 | 0.624 | 196 ± 59 | 218 ± 59 | 0.261 |
RVSP—mmHg + CVP | 28 ± 6 | 29 ± 4 | 0.515 | 26 ± 5 | 26 ± 6 | 0.827 | 25 ± 4 | 29 ± 10 | 0.261 | 27 ± 8 | 26 ± 11 | 0.632 |
GLS (endocardial layer) | − 17 ± 5.3 | − 19 ± 4.1 | 0.107 | − 17 ± 4.8 | − 19 ± 3.4 | 0.877 | − 17 ± 4.4 | − 19 ± 3.7 | 0.735 | − 17 ± 4.6 | − 19 ± 2.7 | 0.608 |
Values are mean ± SD for normally distributed data and median and interquartile range for non-normally distributed data; p-values at baseline were calculated using t test, the p-value for NT-proBNP was assessed by Kruskal–Wallis test; p-values for the intervention effect at day 1, day 3 and month 3 were calculated using the Wald method, eʹ mean is the mean of eʹ septal and eʹ lateral; p-values ≤ 0.05 were categorized as statistically significant
bpm beats per min, CI cardiac index, CVP central venous pressure, DT deceleration time, eGFR estimated glomerular filtration rate, GLS global longitudinal strain, HDL-C high density lipoprotein cholesterol, HR heart rate, IVSd interventricular septum in diastole, LA left atrial, LDL-C low density lipoprotein cholesterol, LV left ventricular, LVEDD left ventricular enddiastolic diameter, LV-EF left ventricular ejection fraction, LVESD left ventricular endsystolic diameter, RVSP right ventricular systolic pressure, SVI stroke volume index, SVRI systemic vascular resistance index