Table 1. Baseline Patient Characteristics by Severe Heart Failure Classification and Treatment Group.
| Characteristic | No. (%) | |||
|---|---|---|---|---|
| Severe heart failure | No severe heart failure | |||
| Omecamtiv mecarbil (n = 1106) | Placebo (n = 1152) | Omecamtiv mecarbil (n = 3014) | Placebo (n = 2960) | |
| Demographic | ||||
| Age, mean (SD), y | 64.4 (11.7) | 64.5 (11.6) | 64.6 (11.2) | 64.5 (11.3) |
| Sex | ||||
| Female | 253 (22.9) | 224 (19.4) | 622 (20.6) | 650 (22.0) |
| Male | 853 (77.1) | 928 (80.6) | 2392 (79.4) | 2310 (78.0) |
| Race | ||||
| Asian | 69 (6.2) | 84 (7.3) | 286 (9.5) | 271 (9.2) |
| Black | 89 (8.0) | 88 (7.6) | 196 (6.5) | 189 (6.4) |
| White | 881 (79.7) | 918 (79.7) | 2315 (76.8) | 2283 (77.1) |
| Othera | 67 (6.1) | 62 (5.4) | 217 (7.2) | 217 (7.3) |
| Geographic region | ||||
| Asia | 66 (6.0) | 75 (6.5) | 269 (8.9) | 260 (8.8) |
| Australasia, South Africa, and western Europe | 279 (25.2) | 270 (23.4) | 682 (22.6) | 690 (23.3) |
| Canada and US | 213 (19.3) | 221 (19.2) | 480 (15.9) | 472 (15.9) |
| Eastern Europe and Russia | 389 (35.2) | 421 (36.5) | 955 (31.7) | 916 (30.9) |
| Latin America | 159 (14.4) | 165 (14.3) | 628 (20.8) | 622 (21.0) |
| Inpatient randomization setting | 440 (39.8) | 497 (43.1) | 604 (20.0) | 543 (18.3) |
| Clinical | ||||
| Atrial fibrillation or flutter at screening | 352 (31.8) | 365 (31.7) | 794 (26.3) | 734 (24.8) |
| History of hypertension | 782 (70.7) | 791 (68.7) | 2128 (70.6) | 2083 (70.4) |
| Type 2 diabetes | 462 (41.8) | 492 (42.7) | 1190 (39.5) | 1165 (39.4) |
| History of stroke | 116 (10.5) | 124 (10.8) | 261 (8.7) | 253 (8.5) |
| Ischemic heart failure | 576 (52.1) | 637 (55.3) | 161 (5.3) | 1585 (53.5) |
| History of myocardial infarction | 443 (40.1) | 517 (44.9) | 1250 (41.5) | 1225 (41.4) |
| LVEF, mean (SD), % | 23.3 (5.3) | 23.5 (5.2) | 27.8 (6.2) | 27.7 (6.3) |
| NYHA class | ||||
| II | 0 | 0 | 2195 (72.8) | 2173 (73.4) |
| III | 1021 (92.3) | 1064 (92.4) | 780 (25.9) | 751 (25.4) |
| IV | 85 (7.7) | 88 (7.6) | 39 (1.3) | 36 (1.2) |
| KCCQ total symptom score, mean (95% CI) | 55.2 (36.5-75.0) | 58.3 (37.5-77.1) | 74.0 (54.2-89.6) | 74.0 (54.2-91.7) |
| Outpatient, mean (95% CI) | 61.5 (41.7-81.2) | 65.6 (46.9-85.4) | 77.1 (58.3-91.7) | 77.1 (58.3-92.2) |
| Inpatient, mean (95% CI) | 46.9 (29.2-68.8) | 47.9 (28.1-65.6) | 59.4 (38.5-77.1) | 56.2 (35.4-74.0) |
| SBP, mean (SD), mm Hg | 114.0 (15.3) | 113.5 (14.7) | 117.1 (15.4) | 117.9 (15.4) |
| Heart rate, mean (SD), beats/min | 74.5 (12.7) | 74.1 (12.3) | 71.7 (12.0) | 71.6 (11.9) |
| NT-proBNP, mean (95% CI), pg/mL | 2758 (1480-5838) | 2834 (1416-5732) | 1753 (864-3479) | 1795 (893-3540) |
| Cardiac troponin I, mean (95% CI), ng/L | 34 (18-64) | 34 (18-64) | 25 (11-47) | 25 (11-47) |
| eGFR, mean (95% CI), mL/min/1.73 m2 | 54.5 (40.9-69.1) | 55.5 (42.5-70.5) | 60.3 (46.1-75.7) | 59.6 (44.8-75.0) |
| Heart failure therapies | ||||
| ACE inhibitor, ARB, or ARN inhibitor | 926 (83.7) | 947 (82.2) | 2657 (88.2) | 2629 (88.8) |
| ARN inhibitor | 218 (19.7) | 229 (19.9) | 601 (19.9) | 553 (18.7) |
| β-blocker | 1019 (92.1) | 1074 (93.2) | 2861 (94.9) | 2809 (94.9) |
| MRA | 869 (78.6) | 899 (78.0) | 2330 (77.3) | 2299 (77.7) |
| SGLT-2 inhibitor | 23 (2.1) | 27 (2.3) | 81 (2.7) | 87 (2.9) |
| Ivabradine | 92 (8.3) | 96 (8.3) | 163 (5.4) | 182 (6.1) |
| Digitalis glycoside | 204 (18.4) | 232 (20.1) | 483 (16.0) | 466 (15.7) |
| Cardiac resynchronization | 183 (16.5) | 189 (16.4) | 409 (13.6) | 377 (12.7) |
| Implantable cardioverter-defibrillator | 402 (36.3) | 405 (35.2) | 924 (30.7) | 883 (29.8) |
Abbreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; ARN, angiotensin receptor neprilysin; eGFR, estimated glomerular filtration rate; KCCQ, Kansas City Cardiomyopathy Questionnaire; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; NT-proBNP, N-terminal pro–B-type natriuretic peptide; NYHA, New York Heart Association; SBP, systolic blood pressure; SGLT2, sodium-glucose cotransporter-2.
a
Specific races and ethnicities included in this category were not reported or available.