Table 1.
Baseline Characteristics of Patients With Anemia at Randomization
| Characteristic | Ferric Derisomaltose (n = 397) | Usual Care (n = 374) |
|---|---|---|
| Age, years | 74 (68–81) | 74 (68–80) |
| Male sex | 319 (80) | 283 (76) |
| Body mass index, kg/m2 | 29 (25–33) | 28 (25–33) |
| Race | ||
| White | 356 (90) | 343 (92) |
| Black | 10 (3) | 5 (1) |
| Asian | 28 (7) | 22 (6) |
| Other | 3 (1) | 4 (1) |
| Recruitment context | ||
| Heart failure predischarge | 66 (17) | 64 (17) |
| Recent (within 6 months) heart failure in-patient | 69 (17) | 70 (19) |
| Outpatient with raised natriuretic peptide level | 262 (66) | 240 (64) |
| NYHA functional classification | ||
| II | 213 (54) | 194 (52) |
| III | 175 (44) | 174 (47) |
| IV | 9 (2) | 6 (2) |
| Heart rate, beats/min | 70 (60–80) | 69 (61–80) |
| Systolic blood pressure, mm Hg | 118 (105–132) | 118 (105–132) |
| Left ventricular ejection fraction, % | 31 (25–37) | 35 (26–37) |
| Principal cause of heart failure | ||
| Ischemic | 233 (59) | 215 (58) |
| Nonischemic | 121 (31) | 122 (33) |
| Unknown | 43 (11) | 37 (10) |
| Prior medical history | ||
| Hospitalization for heart failure | 238 (60) | 222 (59) |
| De novo hospitalization for heart failure | 35 (9) | 39 (10) |
| Atrial fibrillation | 201 (51) | 170 (46) |
| Acute coronary syndrome | 206 (52) | 197 (53) |
| Hypertension | 214 (54) | 212 (57) |
| Diabetes mellitus§ | 191 (48) | 197 (53) |
| Device therapy | ||
| Implantable cardioverter–defibrillator¶ | 54 (14) | 49 (13) |
| Cardiac resynchronization therapy‖ | 95 (24) | 77 (21) |
| Hemoglobin, g/dL | 11.6 (10.8–12.3) | 11.4 (10.8–12.1) |
| TSAT, % | 14 (10–18) | 14 (9–19) |
| Ferritin, µg/L | 49 (28–88) | 47 (28–82) |
| TSAT <20% | 307 (77) | 296 (79) |
| Estimated glomerular filtration rate (calculated by CKD EPI), mL/min/1.73 m2 | 50 (37–67) | 49 (36–67) |
| Heart failure medication | ||
| Loop diuretic | 328 (83) | 317 (85) |
| Angiotensin-converting enzyme inhibitor | 195 (49) | 185 (50) |
| Angiotensin receptor blocker | 58 (15) | 72 (19) |
| Sacubitril–valsartan | 83 (21) | 69 (18) |
| Angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or sacubitril–valsartan | 331 (83) | 322 (86) |
| Beta-blocker | 349 (88) | 332 (89) |
| Mineralocorticoid receptor antagonist | 227 (57) | 205 (55) |
| Digoxin | 48 (12) | 46 (12) |
| Sodium-glucose cotransporter-2 inhibitor | 13 (3) | 8 (2) |
NYHA, New York Heart Association; TSAT, transferrin saturation.
Values are median (interquartile range) or number (%).