Baseline demographics and clinical characteristics of ferric carboxymaltose studies (CONFIRM-HF, AFFIRM-AHF, and HEART-FID) (full analysis population)
| Baseline characteristics . | CONFIRM-HF . | AFFIRM-AHF . | HEART-FID . | Overall . | ||||
|---|---|---|---|---|---|---|---|---|
| FCM (n = 150) . | PBO (n = 151) . | FCM (n = 558) . | PBO (n = 550) . | FCM (n = 1529) . | PBO (n = 1532) . | FCM (n = 2237) . | PBO (n = 2233) . | |
| Age, years | 68.8 (9.5) | 69.5 (9.3) | 71.2 (10.8) | 70.9 (11.1) | 68.6 (10.9) | 68.6 (11.2) | 69.2 (10.9) | 69.2 (11.1) |
| Sex, n (%) | ||||||||
| Male | 83 (55) | 77 (51) | 314 (56) | 300 (55) | 1023 (67) | 1002 (65) | 1420 (64) | 1379 (62) |
| Female | 67 (45) | 74 (49) | 244 (44) | 250 (45) | 506 (33) | 530 (35) | 817 (37) | 854 (38) |
| Race, n (%) | ||||||||
| White | 149 (99) | 150 (99) | 528 (95) | 523 (95) | 1322 (86) | 1324 (86) | 1999 (89) | 1997 (89) |
| Black or African American | 0 (0) | 0 (0) | 3 (1) | 4 (1) | 161 (11) | 160 (10) | 164 (7) | 164 (7) |
| Asian | 0 (0) | 1 (1) | 26 (5) | 22 (4) | 19 (1) | 21 (1) | 45 (2) | 44 (2) |
| Other | 1 (1) | 0 (0) | 1 (<1) | 1 (<1) | 27 (2) | 27 (2) | 29 (1) | 28 (1) |
| Co-morbidities, n (%) | ||||||||
| Previous myocardial infarction | 90 (60) | 90 (60) | 229 (41) | 213 (39) | 730 (47) | 693 (45) | 1049 (52) | 996 (50) |
| Previous stroke | 21 (14) | 24 (16) | 53 (9) | 66 (12) | 172 (11) | 187 (12) | 246 (12) | 277 (14) |
| Previous coronary revascularization | 46 (31) | 39 (26) | 195 (35) | 206 (37) | 746 (49) | 723 (47) | 987 (48) | 968 (48) |
| Hypertension | 130 (87) | 130 (86) | 468 (84) | 471 (86) | 1309 (86) | 1299 (85) | 1907 (88) | 1901 (88) |
| Atrial fibrillation or flutter | 66 (44) | 73 (48) | 314 (56) | 305 (55) | 676 (44) | 664 (43) | 1056 (52) | 1042 (52) |
| Diabetes | 38 (25) | 45 (30) | 227 (41) | 243 (44) | 691 (45) | 691 (45) | 956 (44) | 979 (45) |
| Dyslipidaemia | 98 (65) | 98 (65) | 300 (54) | 292 (53) | 991 (65) | 988 (65) | 1389 (64) | 1378 (64) |
| Smoking | 54 (36) | 41 (27) | 217 (39) | 202 (37) | 745 (49) | 736 (48) | 1016 (47) | 979 (45) |
| NYHA classification, n (%) | ||||||||
| Class I | 14 (3) | 8 (1) | 2 (<1) | 1 (<1) | 16 (1) | 9 (<1) | ||
| Class II | 80 (53) | 91 (60) | 255 (46) | 240 (44) | 795 (52) | 820 (54) | 1130 (51) | 1151 (52) |
| Class III | 70 (47) | 60 (40) | 272 (49) | 277 (50) | 710 (46) | 692 (45) | 1052 (47) | 1029 (46) |
| Class IV | 16 (3) | 22 (4) | 22 (1) | 19 (1) | 38 (2) | 41 (2) | ||
| LVEF, %a | 40.0 (34.0, 43.0) | 39.0 (31.0, 42.0) | 34.0 (25.0, 40.0) | 35.0 (25.0, 40.0) | 33.0 (25.0, 37.0) | 32.0 (25.0, 37.0) | 33.0 (25.0, 38.0) | 33.0 (25.0, 38.0) |
| Ischaemic HF, n (%) | 125 (83) | 126 (83) | 265 (47) | 257 (47) | 935 (61) | 899 (59) | 1325 (59) | 1282 (57) |
| Previous history of HF, n (%) | 150 (100) | 151 (100) | 405 (73) | 385 (70) | 1529 (100) | 1532 (100) | 2084 (93) | 2068 (93) |
| Laboratory test results | ||||||||
| NT-proBNP, pg/mLa | 1453 (476, 2814) | 1277 (481, 2929) | 4743 (2781, 8128) | 4684 (2785, 8695) | 1424 (727, 3045) | 1424 (710, 2884) | 1963 (860, 4254) | 1883 (855, 3970) |
| Hb, g/dLa | 12.4 (11.4, 13.5) | 12.5 (11.4, 13.3) | 12.5 (11.1, 13.6) | 12.3 (11.0, 13.4) | 12.7 (11.7, 13.6) | 12.5 (11.6, 13.5) | 12.6 (11.5, 13.6) | 12.5 (11.4, 13.5) |
| Anaemia, WHO definition, n (%)b | 79 (52.7) | 73 (48.3) | 292 (52.4) | 312 (56.7) | 715 (47.2) | 762 (50.1) | 1086 (48.9) | 1147 (48.4) |
| Serum ferritin, ng/mLa | 46.5 (26.9, 78.1) | 46.0 (24.9, 78.3) | 69.1 (38.7, 104.0) | 67.0 (37.4, 117.0) | 46.8 (26.6, 71.6) | 45.7 (25.0, 71.9) | 51.3 (29.0, 79.8) | 50.2 (27.7, 82.4) |
| Serum ferritin <100 ng/mL, n (%) | 136 (91) | 133 (88) | 408 (73) | 380 (69) | 1362 (89) | 1353 (88) | 1906 (85) | 1866 (84) |
| TSAT, %a | 17.4 (11.1, 25.3) | 17.3 (12.5, 22.4) | 13.8 (9.7, 18.1) | 13.0 (9.2, 18.0) | 23.0 (16.0, 30.0) | 22.0 (16.0, 29.0) | 19.0 (13.0, 28.0) | 19.0 (13.0, 27.0) |
| TSAT ≤20%, n (%) | 90 (60) | 100 (66) | 457 (82) | 469 (85) | 645 (42) | 679 (44) | 1192 (53) | 1248 (56) |
| eGFR, mL/min/1.73 m2a,c | 69.5 (54.8, 85.8) | 64.9 (49.3, 84.1) | 53.1 (39.3, 70.6) | 52.9 (37.8, 72.8) | 57.3 (41.3, 74.1) | 59.2 (43.7, 76.5) | 57.1 (41.3, 74.1) | 58.2 (42.3, 76.0) |
| eGFR <60 mL/min/1.73 m2, n (%)c | 54 (36) | 65 (43) | 292 (52) | 288 (52) | 797 (52) | 749 (49) | 1143 (54) | 1102 (53) |
| Baseline characteristics . | CONFIRM-HF . | AFFIRM-AHF . | HEART-FID . | Overall . | ||||
|---|---|---|---|---|---|---|---|---|
| FCM (n = 150) . | PBO (n = 151) . | FCM (n = 558) . | PBO (n = 550) . | FCM (n = 1529) . | PBO (n = 1532) . | FCM (n = 2237) . | PBO (n = 2233) . | |
| Age, years | 68.8 (9.5) | 69.5 (9.3) | 71.2 (10.8) | 70.9 (11.1) | 68.6 (10.9) | 68.6 (11.2) | 69.2 (10.9) | 69.2 (11.1) |
| Sex, n (%) | ||||||||
| Male | 83 (55) | 77 (51) | 314 (56) | 300 (55) | 1023 (67) | 1002 (65) | 1420 (64) | 1379 (62) |
| Female | 67 (45) | 74 (49) | 244 (44) | 250 (45) | 506 (33) | 530 (35) | 817 (37) | 854 (38) |
| Race, n (%) | ||||||||
| White | 149 (99) | 150 (99) | 528 (95) | 523 (95) | 1322 (86) | 1324 (86) | 1999 (89) | 1997 (89) |
| Black or African American | 0 (0) | 0 (0) | 3 (1) | 4 (1) | 161 (11) | 160 (10) | 164 (7) | 164 (7) |
| Asian | 0 (0) | 1 (1) | 26 (5) | 22 (4) | 19 (1) | 21 (1) | 45 (2) | 44 (2) |
| Other | 1 (1) | 0 (0) | 1 (<1) | 1 (<1) | 27 (2) | 27 (2) | 29 (1) | 28 (1) |
| Co-morbidities, n (%) | ||||||||
| Previous myocardial infarction | 90 (60) | 90 (60) | 229 (41) | 213 (39) | 730 (47) | 693 (45) | 1049 (52) | 996 (50) |
| Previous stroke | 21 (14) | 24 (16) | 53 (9) | 66 (12) | 172 (11) | 187 (12) | 246 (12) | 277 (14) |
| Previous coronary revascularization | 46 (31) | 39 (26) | 195 (35) | 206 (37) | 746 (49) | 723 (47) | 987 (48) | 968 (48) |
| Hypertension | 130 (87) | 130 (86) | 468 (84) | 471 (86) | 1309 (86) | 1299 (85) | 1907 (88) | 1901 (88) |
| Atrial fibrillation or flutter | 66 (44) | 73 (48) | 314 (56) | 305 (55) | 676 (44) | 664 (43) | 1056 (52) | 1042 (52) |
| Diabetes | 38 (25) | 45 (30) | 227 (41) | 243 (44) | 691 (45) | 691 (45) | 956 (44) | 979 (45) |
| Dyslipidaemia | 98 (65) | 98 (65) | 300 (54) | 292 (53) | 991 (65) | 988 (65) | 1389 (64) | 1378 (64) |
| Smoking | 54 (36) | 41 (27) | 217 (39) | 202 (37) | 745 (49) | 736 (48) | 1016 (47) | 979 (45) |
| NYHA classification, n (%) | ||||||||
| Class I | 14 (3) | 8 (1) | 2 (<1) | 1 (<1) | 16 (1) | 9 (<1) | ||
| Class II | 80 (53) | 91 (60) | 255 (46) | 240 (44) | 795 (52) | 820 (54) | 1130 (51) | 1151 (52) |
| Class III | 70 (47) | 60 (40) | 272 (49) | 277 (50) | 710 (46) | 692 (45) | 1052 (47) | 1029 (46) |
| Class IV | 16 (3) | 22 (4) | 22 (1) | 19 (1) | 38 (2) | 41 (2) | ||
| LVEF, %a | 40.0 (34.0, 43.0) | 39.0 (31.0, 42.0) | 34.0 (25.0, 40.0) | 35.0 (25.0, 40.0) | 33.0 (25.0, 37.0) | 32.0 (25.0, 37.0) | 33.0 (25.0, 38.0) | 33.0 (25.0, 38.0) |
| Ischaemic HF, n (%) | 125 (83) | 126 (83) | 265 (47) | 257 (47) | 935 (61) | 899 (59) | 1325 (59) | 1282 (57) |
| Previous history of HF, n (%) | 150 (100) | 151 (100) | 405 (73) | 385 (70) | 1529 (100) | 1532 (100) | 2084 (93) | 2068 (93) |
| Laboratory test results | ||||||||
| NT-proBNP, pg/mLa | 1453 (476, 2814) | 1277 (481, 2929) | 4743 (2781, 8128) | 4684 (2785, 8695) | 1424 (727, 3045) | 1424 (710, 2884) | 1963 (860, 4254) | 1883 (855, 3970) |
| Hb, g/dLa | 12.4 (11.4, 13.5) | 12.5 (11.4, 13.3) | 12.5 (11.1, 13.6) | 12.3 (11.0, 13.4) | 12.7 (11.7, 13.6) | 12.5 (11.6, 13.5) | 12.6 (11.5, 13.6) | 12.5 (11.4, 13.5) |
| Anaemia, WHO definition, n (%)b | 79 (52.7) | 73 (48.3) | 292 (52.4) | 312 (56.7) | 715 (47.2) | 762 (50.1) | 1086 (48.9) | 1147 (48.4) |
| Serum ferritin, ng/mLa | 46.5 (26.9, 78.1) | 46.0 (24.9, 78.3) | 69.1 (38.7, 104.0) | 67.0 (37.4, 117.0) | 46.8 (26.6, 71.6) | 45.7 (25.0, 71.9) | 51.3 (29.0, 79.8) | 50.2 (27.7, 82.4) |
| Serum ferritin <100 ng/mL, n (%) | 136 (91) | 133 (88) | 408 (73) | 380 (69) | 1362 (89) | 1353 (88) | 1906 (85) | 1866 (84) |
| TSAT, %a | 17.4 (11.1, 25.3) | 17.3 (12.5, 22.4) | 13.8 (9.7, 18.1) | 13.0 (9.2, 18.0) | 23.0 (16.0, 30.0) | 22.0 (16.0, 29.0) | 19.0 (13.0, 28.0) | 19.0 (13.0, 27.0) |
| TSAT ≤20%, n (%) | 90 (60) | 100 (66) | 457 (82) | 469 (85) | 645 (42) | 679 (44) | 1192 (53) | 1248 (56) |
| eGFR, mL/min/1.73 m2a,c | 69.5 (54.8, 85.8) | 64.9 (49.3, 84.1) | 53.1 (39.3, 70.6) | 52.9 (37.8, 72.8) | 57.3 (41.3, 74.1) | 59.2 (43.7, 76.5) | 57.1 (41.3, 74.1) | 58.2 (42.3, 76.0) |
| eGFR <60 mL/min/1.73 m2, n (%)c | 54 (36) | 65 (43) | 292 (52) | 288 (52) | 797 (52) | 749 (49) | 1143 (54) | 1102 (53) |
Data are mean (SD) unless otherwise specified.
eGFR, estimated glomerular filtration rate; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; FCM, ferric carboxymaltose; Hb, haemoglobin; HF, heart failure; LVEF, left ventricular ejection fraction; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; NYHA, New York Heart Association; PBO, placebo; SD, standard deviation; TSAT, transferrin saturation; WHO, World Health Organization.
aData are median (upper and lower quartiles).
bDefined as <12 g/dL (female) and <13 g/dL (male).
ceGFR (CKD-EPI) derived using equations specified in statistical analysis plan (see Supplementary data online, Appendix for details).
Baseline demographics and clinical characteristics of ferric carboxymaltose studies (CONFIRM-HF, AFFIRM-AHF, and HEART-FID) (full analysis population)
| Baseline characteristics . | CONFIRM-HF . | AFFIRM-AHF . | HEART-FID . | Overall . | ||||
|---|---|---|---|---|---|---|---|---|
| FCM (n = 150) . | PBO (n = 151) . | FCM (n = 558) . | PBO (n = 550) . | FCM (n = 1529) . | PBO (n = 1532) . | FCM (n = 2237) . | PBO (n = 2233) . | |
| Age, years | 68.8 (9.5) | 69.5 (9.3) | 71.2 (10.8) | 70.9 (11.1) | 68.6 (10.9) | 68.6 (11.2) | 69.2 (10.9) | 69.2 (11.1) |
| Sex, n (%) | ||||||||
| Male | 83 (55) | 77 (51) | 314 (56) | 300 (55) | 1023 (67) | 1002 (65) | 1420 (64) | 1379 (62) |
| Female | 67 (45) | 74 (49) | 244 (44) | 250 (45) | 506 (33) | 530 (35) | 817 (37) | 854 (38) |
| Race, n (%) | ||||||||
| White | 149 (99) | 150 (99) | 528 (95) | 523 (95) | 1322 (86) | 1324 (86) | 1999 (89) | 1997 (89) |
| Black or African American | 0 (0) | 0 (0) | 3 (1) | 4 (1) | 161 (11) | 160 (10) | 164 (7) | 164 (7) |
| Asian | 0 (0) | 1 (1) | 26 (5) | 22 (4) | 19 (1) | 21 (1) | 45 (2) | 44 (2) |
| Other | 1 (1) | 0 (0) | 1 (<1) | 1 (<1) | 27 (2) | 27 (2) | 29 (1) | 28 (1) |
| Co-morbidities, n (%) | ||||||||
| Previous myocardial infarction | 90 (60) | 90 (60) | 229 (41) | 213 (39) | 730 (47) | 693 (45) | 1049 (52) | 996 (50) |
| Previous stroke | 21 (14) | 24 (16) | 53 (9) | 66 (12) | 172 (11) | 187 (12) | 246 (12) | 277 (14) |
| Previous coronary revascularization | 46 (31) | 39 (26) | 195 (35) | 206 (37) | 746 (49) | 723 (47) | 987 (48) | 968 (48) |
| Hypertension | 130 (87) | 130 (86) | 468 (84) | 471 (86) | 1309 (86) | 1299 (85) | 1907 (88) | 1901 (88) |
| Atrial fibrillation or flutter | 66 (44) | 73 (48) | 314 (56) | 305 (55) | 676 (44) | 664 (43) | 1056 (52) | 1042 (52) |
| Diabetes | 38 (25) | 45 (30) | 227 (41) | 243 (44) | 691 (45) | 691 (45) | 956 (44) | 979 (45) |
| Dyslipidaemia | 98 (65) | 98 (65) | 300 (54) | 292 (53) | 991 (65) | 988 (65) | 1389 (64) | 1378 (64) |
| Smoking | 54 (36) | 41 (27) | 217 (39) | 202 (37) | 745 (49) | 736 (48) | 1016 (47) | 979 (45) |
| NYHA classification, n (%) | ||||||||
| Class I | 14 (3) | 8 (1) | 2 (<1) | 1 (<1) | 16 (1) | 9 (<1) | ||
| Class II | 80 (53) | 91 (60) | 255 (46) | 240 (44) | 795 (52) | 820 (54) | 1130 (51) | 1151 (52) |
| Class III | 70 (47) | 60 (40) | 272 (49) | 277 (50) | 710 (46) | 692 (45) | 1052 (47) | 1029 (46) |
| Class IV | 16 (3) | 22 (4) | 22 (1) | 19 (1) | 38 (2) | 41 (2) | ||
| LVEF, %a | 40.0 (34.0, 43.0) | 39.0 (31.0, 42.0) | 34.0 (25.0, 40.0) | 35.0 (25.0, 40.0) | 33.0 (25.0, 37.0) | 32.0 (25.0, 37.0) | 33.0 (25.0, 38.0) | 33.0 (25.0, 38.0) |
| Ischaemic HF, n (%) | 125 (83) | 126 (83) | 265 (47) | 257 (47) | 935 (61) | 899 (59) | 1325 (59) | 1282 (57) |
| Previous history of HF, n (%) | 150 (100) | 151 (100) | 405 (73) | 385 (70) | 1529 (100) | 1532 (100) | 2084 (93) | 2068 (93) |
| Laboratory test results | ||||||||
| NT-proBNP, pg/mLa | 1453 (476, 2814) | 1277 (481, 2929) | 4743 (2781, 8128) | 4684 (2785, 8695) | 1424 (727, 3045) | 1424 (710, 2884) | 1963 (860, 4254) | 1883 (855, 3970) |
| Hb, g/dLa | 12.4 (11.4, 13.5) | 12.5 (11.4, 13.3) | 12.5 (11.1, 13.6) | 12.3 (11.0, 13.4) | 12.7 (11.7, 13.6) | 12.5 (11.6, 13.5) | 12.6 (11.5, 13.6) | 12.5 (11.4, 13.5) |
| Anaemia, WHO definition, n (%)b | 79 (52.7) | 73 (48.3) | 292 (52.4) | 312 (56.7) | 715 (47.2) | 762 (50.1) | 1086 (48.9) | 1147 (48.4) |
| Serum ferritin, ng/mLa | 46.5 (26.9, 78.1) | 46.0 (24.9, 78.3) | 69.1 (38.7, 104.0) | 67.0 (37.4, 117.0) | 46.8 (26.6, 71.6) | 45.7 (25.0, 71.9) | 51.3 (29.0, 79.8) | 50.2 (27.7, 82.4) |
| Serum ferritin <100 ng/mL, n (%) | 136 (91) | 133 (88) | 408 (73) | 380 (69) | 1362 (89) | 1353 (88) | 1906 (85) | 1866 (84) |
| TSAT, %a | 17.4 (11.1, 25.3) | 17.3 (12.5, 22.4) | 13.8 (9.7, 18.1) | 13.0 (9.2, 18.0) | 23.0 (16.0, 30.0) | 22.0 (16.0, 29.0) | 19.0 (13.0, 28.0) | 19.0 (13.0, 27.0) |
| TSAT ≤20%, n (%) | 90 (60) | 100 (66) | 457 (82) | 469 (85) | 645 (42) | 679 (44) | 1192 (53) | 1248 (56) |
| eGFR, mL/min/1.73 m2a,c | 69.5 (54.8, 85.8) | 64.9 (49.3, 84.1) | 53.1 (39.3, 70.6) | 52.9 (37.8, 72.8) | 57.3 (41.3, 74.1) | 59.2 (43.7, 76.5) | 57.1 (41.3, 74.1) | 58.2 (42.3, 76.0) |
| eGFR <60 mL/min/1.73 m2, n (%)c | 54 (36) | 65 (43) | 292 (52) | 288 (52) | 797 (52) | 749 (49) | 1143 (54) | 1102 (53) |
| Baseline characteristics . | CONFIRM-HF . | AFFIRM-AHF . | HEART-FID . | Overall . | ||||
|---|---|---|---|---|---|---|---|---|
| FCM (n = 150) . | PBO (n = 151) . | FCM (n = 558) . | PBO (n = 550) . | FCM (n = 1529) . | PBO (n = 1532) . | FCM (n = 2237) . | PBO (n = 2233) . | |
| Age, years | 68.8 (9.5) | 69.5 (9.3) | 71.2 (10.8) | 70.9 (11.1) | 68.6 (10.9) | 68.6 (11.2) | 69.2 (10.9) | 69.2 (11.1) |
| Sex, n (%) | ||||||||
| Male | 83 (55) | 77 (51) | 314 (56) | 300 (55) | 1023 (67) | 1002 (65) | 1420 (64) | 1379 (62) |
| Female | 67 (45) | 74 (49) | 244 (44) | 250 (45) | 506 (33) | 530 (35) | 817 (37) | 854 (38) |
| Race, n (%) | ||||||||
| White | 149 (99) | 150 (99) | 528 (95) | 523 (95) | 1322 (86) | 1324 (86) | 1999 (89) | 1997 (89) |
| Black or African American | 0 (0) | 0 (0) | 3 (1) | 4 (1) | 161 (11) | 160 (10) | 164 (7) | 164 (7) |
| Asian | 0 (0) | 1 (1) | 26 (5) | 22 (4) | 19 (1) | 21 (1) | 45 (2) | 44 (2) |
| Other | 1 (1) | 0 (0) | 1 (<1) | 1 (<1) | 27 (2) | 27 (2) | 29 (1) | 28 (1) |
| Co-morbidities, n (%) | ||||||||
| Previous myocardial infarction | 90 (60) | 90 (60) | 229 (41) | 213 (39) | 730 (47) | 693 (45) | 1049 (52) | 996 (50) |
| Previous stroke | 21 (14) | 24 (16) | 53 (9) | 66 (12) | 172 (11) | 187 (12) | 246 (12) | 277 (14) |
| Previous coronary revascularization | 46 (31) | 39 (26) | 195 (35) | 206 (37) | 746 (49) | 723 (47) | 987 (48) | 968 (48) |
| Hypertension | 130 (87) | 130 (86) | 468 (84) | 471 (86) | 1309 (86) | 1299 (85) | 1907 (88) | 1901 (88) |
| Atrial fibrillation or flutter | 66 (44) | 73 (48) | 314 (56) | 305 (55) | 676 (44) | 664 (43) | 1056 (52) | 1042 (52) |
| Diabetes | 38 (25) | 45 (30) | 227 (41) | 243 (44) | 691 (45) | 691 (45) | 956 (44) | 979 (45) |
| Dyslipidaemia | 98 (65) | 98 (65) | 300 (54) | 292 (53) | 991 (65) | 988 (65) | 1389 (64) | 1378 (64) |
| Smoking | 54 (36) | 41 (27) | 217 (39) | 202 (37) | 745 (49) | 736 (48) | 1016 (47) | 979 (45) |
| NYHA classification, n (%) | ||||||||
| Class I | 14 (3) | 8 (1) | 2 (<1) | 1 (<1) | 16 (1) | 9 (<1) | ||
| Class II | 80 (53) | 91 (60) | 255 (46) | 240 (44) | 795 (52) | 820 (54) | 1130 (51) | 1151 (52) |
| Class III | 70 (47) | 60 (40) | 272 (49) | 277 (50) | 710 (46) | 692 (45) | 1052 (47) | 1029 (46) |
| Class IV | 16 (3) | 22 (4) | 22 (1) | 19 (1) | 38 (2) | 41 (2) | ||
| LVEF, %a | 40.0 (34.0, 43.0) | 39.0 (31.0, 42.0) | 34.0 (25.0, 40.0) | 35.0 (25.0, 40.0) | 33.0 (25.0, 37.0) | 32.0 (25.0, 37.0) | 33.0 (25.0, 38.0) | 33.0 (25.0, 38.0) |
| Ischaemic HF, n (%) | 125 (83) | 126 (83) | 265 (47) | 257 (47) | 935 (61) | 899 (59) | 1325 (59) | 1282 (57) |
| Previous history of HF, n (%) | 150 (100) | 151 (100) | 405 (73) | 385 (70) | 1529 (100) | 1532 (100) | 2084 (93) | 2068 (93) |
| Laboratory test results | ||||||||
| NT-proBNP, pg/mLa | 1453 (476, 2814) | 1277 (481, 2929) | 4743 (2781, 8128) | 4684 (2785, 8695) | 1424 (727, 3045) | 1424 (710, 2884) | 1963 (860, 4254) | 1883 (855, 3970) |
| Hb, g/dLa | 12.4 (11.4, 13.5) | 12.5 (11.4, 13.3) | 12.5 (11.1, 13.6) | 12.3 (11.0, 13.4) | 12.7 (11.7, 13.6) | 12.5 (11.6, 13.5) | 12.6 (11.5, 13.6) | 12.5 (11.4, 13.5) |
| Anaemia, WHO definition, n (%)b | 79 (52.7) | 73 (48.3) | 292 (52.4) | 312 (56.7) | 715 (47.2) | 762 (50.1) | 1086 (48.9) | 1147 (48.4) |
| Serum ferritin, ng/mLa | 46.5 (26.9, 78.1) | 46.0 (24.9, 78.3) | 69.1 (38.7, 104.0) | 67.0 (37.4, 117.0) | 46.8 (26.6, 71.6) | 45.7 (25.0, 71.9) | 51.3 (29.0, 79.8) | 50.2 (27.7, 82.4) |
| Serum ferritin <100 ng/mL, n (%) | 136 (91) | 133 (88) | 408 (73) | 380 (69) | 1362 (89) | 1353 (88) | 1906 (85) | 1866 (84) |
| TSAT, %a | 17.4 (11.1, 25.3) | 17.3 (12.5, 22.4) | 13.8 (9.7, 18.1) | 13.0 (9.2, 18.0) | 23.0 (16.0, 30.0) | 22.0 (16.0, 29.0) | 19.0 (13.0, 28.0) | 19.0 (13.0, 27.0) |
| TSAT ≤20%, n (%) | 90 (60) | 100 (66) | 457 (82) | 469 (85) | 645 (42) | 679 (44) | 1192 (53) | 1248 (56) |
| eGFR, mL/min/1.73 m2a,c | 69.5 (54.8, 85.8) | 64.9 (49.3, 84.1) | 53.1 (39.3, 70.6) | 52.9 (37.8, 72.8) | 57.3 (41.3, 74.1) | 59.2 (43.7, 76.5) | 57.1 (41.3, 74.1) | 58.2 (42.3, 76.0) |
| eGFR <60 mL/min/1.73 m2, n (%)c | 54 (36) | 65 (43) | 292 (52) | 288 (52) | 797 (52) | 749 (49) | 1143 (54) | 1102 (53) |
Data are mean (SD) unless otherwise specified.
eGFR, estimated glomerular filtration rate; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; FCM, ferric carboxymaltose; Hb, haemoglobin; HF, heart failure; LVEF, left ventricular ejection fraction; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; NYHA, New York Heart Association; PBO, placebo; SD, standard deviation; TSAT, transferrin saturation; WHO, World Health Organization.
aData are median (upper and lower quartiles).
bDefined as <12 g/dL (female) and <13 g/dL (male).
ceGFR (CKD-EPI) derived using equations specified in statistical analysis plan (see Supplementary data online, Appendix for details).
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