Table 1.
Characteristics of patients at baselinea
| Ferric carboxymaltose (N = 535) | Placebo (N = 523) | |
|---|---|---|
| Age (years) | 71.0 ± 10.85 | 70.9 ± 11.3 |
| Sex | ||
| Male | 298 (55.7) | 283 (54.1) |
| Female | 237 (44.3) | 240 (45.9) |
| Race | ||
| White | 509 (95.1) | 499 (95.4) |
| Other | 26 (4.9) | 24 (4.6) |
| Comorbidities | ||
| Previous myocardial infarction | 220 (41.1) | 206 (39.4) |
| Previous stroke | 51 (9.5) | 63 (12.0) |
| Previous coronary revascularization | 187 (35.0) | 197 (37.7) |
| Hypertension | 449 (83.9) | 448 (85.7) |
| Atrial fibrillation | 303 (56.6) | 286 (54.7) |
| Diabetes mellitus | 222 (41.5) | 228 (43.6) |
| Dyslipidaemia | 287 (53.6) | 275 (52.6) |
| Chronic kidney disease | 211 (39.4) | 215 (41.1) |
| Smoking (current) | 54 (10.1) | 48 (9.2) |
| Smoking (former) | 154 (28.8) | 144 (27.5) |
| Body mass index (kg/m2) | 28.2 ± 5.7 | 28.1 ± 5.7 |
| NYHA functional class | ||
| I | 14 (2.6) | 8 (1.5) |
| II | 242 (45.3) | 229 (44.0) |
| III | 263 (49.3) | 263 (50.6) |
| IV | 15 (2.8) | 20 (3.8) |
| Left ventricular ejection fraction (%)b | 32.8 ± 9.6 | 32.8 ± 9.9 |
| Left ventricular ejection fractionb | ||
| <25% | 99 (18.5) | 113 (21.6) |
| 25–39% | 272 (50.8) | 234 (44.8) |
| 40–49% | 164 (30.7) | 175 (33.5) |
| Ischaemic aetiology of HF | 255 (47.7) | 246 (47.0) |
| Device therapy | ||
| Implantable cardioverter-defibrillator | 64 (12.0) | 60 (11.5) |
| Cardiac resynchronization therapy | 31 (5.8) | 30 (5.7) |
| Heart failure history | ||
| Newly diagnosed at index hospitalization | 144 (26.9) | 153 (29.3) |
| Hospitalization for heart failure in previous 12 months | 142 (36.3) | 145 (39.2) |
| Pharmacotherapy | ||
| Angiotensin-converting enzyme inhibitor | 297 (55.5) | 282 (53.9) |
| Angiotensin II receptor blocker | 123 (23.0) | 103 (19.7) |
| Angiotensin receptor-neprilysin inhibitor | 27 (5.0) | 27 (5.2) |
| Mineralocorticoid receptor antagonist | 344 (64.3) | 346 (66.2) |
| Beta-blocker | 392 (73.3) | 397 (75.9) |
| Digitalis glycosides | 110 (20.6) | 109 (20.8) |
| Loop diuretic | 532 (99.4) | 522 (99.8) |
| KCCQ-12 | ||
| Overall summary score, mean (±SE) | 38.1 (±0.9) | 37.1 (±0.8) |
| Clinical summary score, mean (±SE) | 40.9 (±0.9) | 40.1 (±0.9) |
| Laboratory test results | ||
| Median NT-proBNP (Q1, Q3) (pg/mL) | 4657 (2724, 8060) | 4654 (2758, 8780) |
| Median BNP (Q1, Q3) (pg/mL) | 1076 (820, 1715) | 1170 (797, 1964) |
| Haemoglobin (g/dL) | 12.2 ± 1.6 | 12.15 ± 1.6 |
| Anaemia | ||
| Adult males (Hb <13 g/dL) | 171 (32) | 172 (32.9) |
| Adult females, non-pregnant (Hb <12 g/dL) | 108 (20.2) | 124 (23.7) |
| Ferritin (ng/mL) | 84.3 ± 63.0 | 87.65 ± 67.5 |
| Ferritin <100 ng/mL | 390 (73.0) | 362 (69.2) |
| Transferrin saturation (%) | 15.2 ± 8.4 | 14.3 ± 7.6 |
| Transferrin saturation <20% | 439 (82.7) | 444 (85.4) |
| eGFR (mL/min/1.73 m2) | 55.7 ± 21.3 | 56.0 ± 23.1 |
| Phosphorus | ||
| 2.5–4.4 mg/dL | 442 (87.0) | 408 (81.6) |
| ≥4.5 mg/dL | 46 (9.1) | 80 (16.0) |
Data are mean ± standard deviation or n (%) unless otherwise indicated. Percentages might not add to 100% because of rounding.
BNP, B-type natriuretic peptide; eGFR, estimated glomerular filtration rate; Hb, haemoglobin; KCCQ-12, 12-item Kansas City Cardiomyopathy Questionnaire; NT-proBNP, N-terminal pro B-type natriuretic peptide; NYHA, New York Heart Association.
a
With a baseline KCCQ-12.
b
Left ventricular ejection fraction was measured within a maximum of 12 months before randomization.