Table 1.
Characteristics of the patients according to treatment arm.
| All | Placebo arm | Spironolactone arm | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Women (n = 898) | Men (n = 721) | p | Women (n = 445) | Men (n = 363) | p | Women (n = 453) | Men (n = 358) | p | |
| Age, years | 77.0 ± 5.3 | 77.1 ± 5.1 | 0.458 | 76.6 ± 0.2 | 77 ± 0.3 | 0.116 | 77.4 ± 0.3 | 77.2 ± 0.3 | 0.621 |
| Region | |||||||||
| Americas, n (%) | 533 (59.4) | 498 (69.1) | <0.001 | 255 (56.0) | 252 (69.4) | <0.001 | 278 (61.4) | 246 (68.7) | 0.03 |
| Russia/Georgia, n (%) | 365 (40.6) | 223 (30.9) | <0.001 | 190 (42.7) | 111 (30.6) | <0.001 | 175 (38.6) | 112 (31.3) | 0.03 |
| Atrial fibrillation, n (%) | 371 (41.4) | 341 (47.4) | 0.016 | 188 (42.2) | 164 (45.2) | 0.399 | 183 (40.4) | 177 (49.4) | 0.01 |
| Coronary artery disease | |||||||||
| Angina, n (%) | 363 (40.4) | 316 (43.9) | 0.166 | 193 (43.4) | 164 (45.2) | 0.602 | 170 (37.5) | 152 (42.5) | 0.154 |
| MI, n (%) | 168 (18.7) | 223 (30.9) | <0.001 | 86 (19.3) | 120 (33.1) | <0.001 | 82 (18.1) | 103 (28.8) | <0.001 |
| CABG, n (%) | 68 (7.6) | 161 (22.3) | <0.001 | 41 (9.2) | 89 (24.5) | <0.001 | 27 (6.0) | 72 (20.1) | <0.001 |
| PCI, n (%) | 11 2(12.5) | 136 (18.9) | <0.001 | 49 (11.0) | 76 (20.9) | <0.001 | 63 (13.9) | 60 (16.8) | 0.261 |
| Hypertension, n (%) | 835 (93.0) | 643 (89.2) | 0.007 | 417 (93.7) | 326 (89.8) | 0.042 | 418 (92.3) | 317 (88.5) | 0.071 |
| Diabetes mellitus, n (%) | 252 (28.1) | 229 (31.2) | 0.105 | 117 (26.3) | 123 (33.9) | 0.019 | 135 (29.8) | 106 (29.6) | 0.953 |
| Dyslipidemia, n (%) | 515 (57.3) | 477 (66.2) | <0.001 | 258 (58.0) | 250 (68.9) | 0.001 | 257 (56.7) | 227 (63.4) | 0.054 |
| Tobacco use, n (%) | 224 (24.8) | 482 (66.9) | <0.001 | 114 (25.6) | 236 (65.0) | <0.001 | 110 (24.3) | 246 (67.8) | <0.001 |
| COPD, n (%) | 83 (9.24) | 118 (47.4) | <0.001 | 39 (8.6) | 63 (17.6) | <0.001 | 44 (9.7) | 55 (15.4) | 0.015 |
| Heart rate, beats/min | 69.0 ± 10.4 | 67.2 ± 10.2 | 0.002 | 69.0 ± 0.5 | 67.5 ± 0.5 | 0.049 | 69.1 ± 0.5 | 66.8 ± 0.6 | 0.013 |
| SBP, mmHg | 130.5 ± 14.3 | 126.8 ± 13.5 | <0.001 | 131.1 ± 0.7 | 126.6 ± 0.7 | <0.001 | 129.9 ± 0.7 | 127.1 ± 0.7 | 0.009 |
| DBP, mmHg | 74.5 ± 11.1 | 71.9 ± 10.7 | <0.001 | 74.5 ± 0.6 | 71.6 ± 0.6 | <0.001 | 72.5 ± 0.5 | 72.1 ± 0.6 | 0.006 |
| Body mass index, kg/m 2 | 30.9 ± 6.2 | 30.1 ± 5.8 | 0.011 | 31.0 ± 0.3 | 30.0 ± 0.3 | 0.024 | 30.7 ± 0.3 | 30.1 ± 0.3 | 0.164 |
| Serum potassium, mmol/L | 4.2 ± 0.4 | 4.3 ± 0.5 | 0.01 | 4.3 ± 0.0 | 4.29 ± 0.0 | 0.108 | 4.2 ± 0.2 | 4.3 ± 0.0 | 0.349 |
| Blood urea nitrogen, mg/dl | 16.2 ± 14.2 | 20.1 ± 14.3 | <0.001 | 16.9 ± 0.7 | 18.8 ± 0.7 | 0.005 | 15.4 ± 0.6 | 21.4 ± 0.8 | <0.001 |
| Creatinine, mg/dl | 1.0 ± 0.3 | 1.3 ± 0.3 | <0.001 | 1.0 ± 0.0 | 1.2 ± 0.0 | <0.001 | 1.0 ± 0.0 | 1.3 ± 0.0 | <0.001 |
| Estimated GFR, ml/min/1.73 m 2 | 60.8 ± 17.6 | 64.2 ± 17.5 | <0.001 | 60.0 ± 0.8 | 65.1 ± 1.0 | <0.001 | 61.5 ± 0.8 | 63.3 ± 0.9 | 0.073 |
| Hemoglobin, g/dL | 12.6 ± 1.8 | 13.3 ± 2.4 | <0.001 | 12.8 ± 0.1 | 13.2 ± 0.1 | <0.001 | 12.5 ± 0.1 | 13.4 ± 0.1 | <0.001 |
| NYHA functional classes III–IV, n (%) | 346 (38.5) | 227 (31.5) | 0.003 | 172 (38.7) | 104 (28.7) | 0.003 | 174 (38.4) | 123 (34.4) | 0.234 |
| LVEF (%) | 63.3 ± 0.5 | 58.9 ± 0.6 | 0.001 | 61.3 ± 0.7 | 59.3 ± 0.8 | 0.031 | 61.4 ± 0.6 | 58.5 ± 0.9 | 0.012 |
| E (cm/s) | 86.3 ± 26.9 | 86.7 ± 29.1 | 0.37 | 85.2 ± 24.8 | 88.6 ± 29.1 | 0.381 | 87.2 ± 28.7 | 84.6 ± 29.0 | 0.727 |
| A (cm/s) | 81.5 ± 25.2 | 71.1 ± 26.8 | <0.001 | 83.9 ± 25.1 | 7.6 ± 26.0 | 0.001 | 79.3 ± 25.3 | 71.9 ± 27.9 | 0.11 |
| E/A | 1.1 ± 0.7 | 1.2 ± 0.7 | 0.108 | 1.1 ± 0.7 | 1.3 ± 0.7 | 0.064 | 1.2 ± 0.7 | 1.2 ± 0.7 | 0.712 |
| EDT (s) | 210.4 ± 65.2 | 201.6 ± 67.1 | 0.154 | 210 ± 73.5 | 198.5 ± 63.9 | 0.381 | 210.8 ± 57.3 | 205.1 ± 70.8 | 0.249 |
| E/Em septal | 16.5 ± 6.7 | 15.9 ± 7.7 | 0.262 | 16.3 ± 5.8 | 15.8 ± 7.5 | 0.345 | 16.6 ± 7.5 | 15.8 ± 8.0 | 0.513 |
| E/Em lateral | 12.5 ± 6.4 | 11.5 ± 5.9 | 0.142 | 12.6 ± 5.3 | 11.8 ± 6.3 | 0.149 | 12.4 ± 7.2 | 11.2 ± 5.5 | 0.436 |
| BNP (pg/ml) | 245 [148, 431] | 302 [165, 483] | 0.039 | 241.5 [147.5, 389.5] | 307 [159, 454] | 0.094 | 245 [151, 472] | 284.5 [170,502] | 0.234 |
| NT-proBNP (pg/ml) | 889 [485,1914] | 901 [532, 1,908] | 0.787 | 971 [560, 2,276] | 904.5 [540.5, 2,025] | 0.437 | 802 [435, 1,650] | 901 [517, 1,790] | 0.378 |
| KCCQ overall score | 54.1 ± 19.9 | 61.9 ± 21.3 | <0.001 | 53.8 ± 0.9 | 61.8 ± 1.1 | <0.001 | 54.3 ± 1.0 | 62.0 ± 1.2 | <0.001 |
| PHQ-9 score | 5.3 ± 9.2 | 4.8 ± 8.8 | 0.065 | 5.5 ± 0.6 | 4.1 ± 0.8 | 0.078 | 5.0 ± 0.7 | 5.4 ± 0.3 | 0.377 |
| Any antihypertensive drugs, n (%) | 892 (99.4) | 713 (99.0) | 0.334 | 441 (99.1) | 360 (99.2) | 0.825 | 451 (99.6) | 353 (98.6) | 0.144 |
| ACEI or ARB, n (%) | 730 (81.4) | 568 (78.9) | 0.21 | 365 (82.0) | 282 (77.7) | 0.126 | 365 (80.6) | 286 (80.0) | 0.807 |
| Beta-blocker, n (%) | 670 (74.7) | 558 (77.5) | 0.189 | 333 (74.8) | 286 (78.8) | 0.18 | 337 (74.4) | 272 (76.0) | 0.604 |
| CCB, n (%) | 356 (39.7) | 256 (35.6) | 0.089 | 186 (41.8) | 125 (34.4) | 0.033 | 170 (37.5) | 131 (36.6) | 0.784 |
| Diuretic, n (%) | 754 (84.1) | 604 (83.9) | 0.927 | 378 (84.9) | 309 (85.1) | 0.929 | 376 (83.0) | 295 (82.4) | 0.822 |
| Other antihypertensive drugs, n (%) | 110 (12.3) | 115 (16.0) | 0.032 | 56 (12.6) | 55 (15.2) | 0.29 | 54 (11.9) | 60 (16.8) | 0.049 |
| Aspirin, n (%) | 552 (61.5) | 460 (63.9) | 0.332 | 278 (62.5) | 233 (64.2) | 0.608 | 274 (60.5) | 227 (63.4) | 0.395 |
| Nitrate, n (%) | 143 (15.9) | 113 (15.7) | 0.892 | 73 (16.4) | 57 (15.7) | 0.789 | 70 (15.5) | 56 (15.6) | 0.941 |
| Any hypoglycemic, n (%) | 202 (22.5) | 195 (27.1) | 0.034 | 93 (20.9) | 103 (28.4) | 0.013 | 109 (24.1) | 92 (25.7) | 0.592 |
| Statin, n (%) | 420 (46.8) | 445 (61.8) | <0.001 | 204 (45.8) | 220 (60.6) | <0.001 | 216 (47.7) | 225 (62.8) | <0.001 |
| Warfarin, n (%) | 231 (25.8) | 229 (31.8) | 0.007 | 116 (26.1) | 115 (31.7) | 0.078 | 115 (25.4) | 114 (31.8) | 0.043 |
| Other CV medication, n (%) | 396 (44.1) | 410 (56.9) | <0.001 | 192 (43.1) | 207 (57.0) | <0.001 | 204 (45.0) | 203 (56.7) | 0.001 |
| Selective serotonin reuptake inhibitor, n (%) | 78 (8.7) | 50 (6.9) | 0.195 | 39 (87.6) | 26 (7.2) | 0.406 | 39 (8.6) | 24 (6.7) | 0.314 |
Values are mean ± SD or n (%).
>CABG, coronary artery bypass graft; PCI, percutaneous coronary intervention; COPD, chronic obstructive pulmonary disease; GFR, glomerular filtration rate; HF, heart failure; LVEF, left ventricular ejection fraction; MI, myocardial infarction; SBP, systolic blood pressure; DBP, diastolic blood pressure; KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association; PHQ-9, Patient Health Questionnaire 9th edition; ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; CCB, calcium channel blocker; CV, cardiovascular; E, early mitral inflow velocity; A, late mitral inflow velocity; E/A, early to late mitral inflow velocity ratio; EDT, E wave deceleration time; E/Em, mitral inflow to mitral relaxation velocity ratio.