TABLE 1.
Baseline characteristics by treatment arm according to different cut points of left and right ventricular ejection fraction at enrolment
| Variables | LVEF < 40% | P‐value | LVEF < 45% | P‐value | RVEF < 45% | P‐value | RVEF < 51% in women or <52% in men | P‐value | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n (%) | 27 (50.9) | 38 (71.7) | 10 (18.9%) | 17 (32.1%) | ||||||||
| Treatment arm | Placebo | Iron | Placebo | Iron | Placebo | Iron | Placebo | Iron | ||||
| n (%) | 17 (63) | 10 (37) | 20 (53) | 18 (47) | 4 (40) | 6 (60) | 7 (41) | 10 (59) | ||||
| Demographics and medical history | ||||||||||||
| Age (years) | 71 (67–73) | 70 (64–75) | 0.651 | 71 (65–78) | 73 (64–77) | 0.861 | 73 (68–82) | 67 (61–73) | 0.861 | 73 (67–78) | 65 (62–73) | 0.051 |
| Male, n (%) | 14 (82) | 10 (100) | 0.232 | 17 (85) | 14 (78) | 0.437 | 3 (75) | 4 (67) | 0.667 | 6 (86) | 7 (70) | 0.441 |
| Hypertension, n (%) | 12 (71) | 8 (80) | 0.475 | 13 (65) | 14 (78) | 0.307 | 4 (100) | 4 (67) | 0.333 | 5 (71) | 8 (80) | 0.559 |
| Diabetes mellitus, n (%) | 9 (53) | 9 (90) | 0.057 | 10 (50) | 12 (67) | 0.239 | 3 (75) | 3 (50) | 0.452 | 6 (86) | 6 (60) | 0.278 |
| Dyslipidaemia, n (%) | 11 (65) | 9 (90) | 0.161 | 12 (60) | 15 (83) | 0.110 | 4 (100) | 6 (100) | 1.000 | 5 (71) | 8 (80) | 0.559 |
| History of IHD, n (%) | 7 (41) | 6 (60) | 0.293 | 8 (40) | 8 (44) | 0.520 | 0 (0) | 1 (17) | 0.600 | 1 (14) | 3 (30) | 0.441 |
| Admission for AHF in last year, n (%) | 11 (65) | 5 (50) | 0.363 | 13 (65) | 10 (55) | 0.396 | 1 (25) | 4 (67) | 0.262 | 4 (57) | 5 (50) | 0.581 |
| History of atrial fibrillation, n (%) | 9 (53) | 3 (30) | 0.226 | 11 (55) | 5 (28) | 0.085 | 3 (75) | 3 (50) | 0.452 | 5 (71) | 5 (50) | 0.354 |
| Vital signs | ||||||||||||
| HR at baseline (b.p.m.) | 68 (64–84) | 73 (71–80) | 0.763 | 68 (64–81) | 73 (67–80) | 0.753 | 92 (71–104) | 77 (73–80) | 0.588 | 84 (59–100) | 79 (73–86) | 0.845 |
| Systolic blood pressure (mmHg) | 123 (113–131) | 111 (97–120) | 0.138 | 124 (113–139) | 118 (109–132) | 0.306 | 122 (120–125) | 105 (90–117) | 0.306 | 122 (113–129) | 111 (97–120) | 0.187 |
| Diastolic blood pressure (mmHg) | 66 (63–73) | 62 (58–68) | 0.151 | 66 (62–74) | 63 (58–70) | 0.232 | 68 (59–75) | 65 (59–70) | 0.213 | 65 (61–75) | 65 (59–70) | 0.353 |
| Laboratory | ||||||||||||
| Haemoglobin (g/dL) | 13.7 (13.1–14.6) | 13.2 (13–13.3) | 0.152 | 13.6 (12.9–14.6) | 12.8 (11.9–13.3) | 0.018 | 14.5 (13.6–14.7) | 12.7 (11.9–13.3) | 0.018 | 14.4 (12.8–14.8) | 12.9 (11.9–13.3) | 0.117 |
| Haematocrit (%) | 44.0 (40.6–45) | 41.5 (38.1–43) | 0.258 | 43.7 (40.5–45) | 39.6 (38–43) | 0.025 | 46.1 (43.1–47.5) | 40.0 (38–43) | 0.025 | 45.3 (41–47.2) | 41.5 (38–43) | 0.129 |
| Transferrin saturation (%) | 14.9 (9.0–20.5) | 15.3 (12.0–19.2) | 0.821 | 14.5 (9.3–20.2) | 14.1 (11.0–19.2) | 0.815 | 12.2 (9.6–18.4) | 14.1 (12–16) | 0.815 | 9.6 (9–14.9) | 14.1 (12–16) | 0.241 |
| Ferritin (ng/mL) | 48 (30–85) | 61 (56–81) | 0.353 | 48 (26–88) | 61 (48–99) | 0.273 | 36 (23–45) | 72 (56–271) | 0.273 | 42.0 (25–48) | 74 (59–101) | 0.004 |
| Creatinine (mg/dL) | 1.11 (0.95–1.46) | 1.11 (0.94–1.24) | 0.812 | 1.18 (0.95–1.51) | 1.12 (0.97–1.39) | 0.826 | 1.29 (1.06–1.44) | 1.05 (0.94–1.52) | 0.826 | 1.42 (1.11–1.48) | 1.12 (0.94–1.61) | 0.696 |
| eGFR (mL/min/1.73 m2) | 67.6 (46.8–79.3) | 69.6 (59.4–86.1) | 0.379 | 58.4 (45.5–79.2) | 59.7 (51.8–71.3) | 0.826 | 49.5 (48–64.5) | 62.0 (45–86.1) | 0.803 | 49.3 (46.8–70.6) | 58.4 (41.9.71.3) | 0.922 |
| Serum sodium (mEq/L) | 141 (140–142) | 140 (138–142) | 0.761 | 140 (139–142) | 140 (138–142) | 0.614 | 139 (136–141) | 140 (138–141) | 0.614 | 141 (137–144) | 140 (138–142) | 0.806 |
| NT‐proBNP (pg/mL) | 1760 (1026–2667) | 2628 (1728–2836) | 0.303 | 1503 (976–2898) | 2269 (1220–2836) | 0.511 | 2083 (1508–2352) | 3190 (2110–4998) | 0.502 | 2177 (1760–3999) | 2738 (2110–3952) | 0.588 |
| CMR parameters | ||||||||||||
| LVEDVI (mL/m2) | 119 (105–137) | 128 (104–148) | 0.900 | 122 (101–141) | 111 (98–141) | 0.334 | 115 (98–127) | 110 (73–141) | 0.334 | 105 (91–126) | 110 (78–141) | 0.922 |
| LVESVI (mL/m2) | 85 (68–99) | 86 (72–101) | 0.920 | 83 (67–95) | 73 (54–87) | 0.156 | 78 (62–94) | 73 (46–87) | 0.152 | 68 (55–89) | 64 (46–87) | 0.588 |
| LVEF (%) a | 31.7 ± 5.6 | 32.0 ± 5.3 | 0.919 | 33.6 ± 6.8 | 37.1 ± 7.2 | 0.912 | 31.7 ± 7.1 | 35.2 ± 7.3 | 0.139 | 34.4 ± 7.4 | 39 ± 6 | 0.238 |
| LVEF (%) | 33 (28–36) | 32 (27–38) | 0.919 | 34 (29–38) | 38 (31–44) | 0.139 | 33 (27–37) | 38 (27–41) | 0.280 | 36 (30–39) | 39 (38–44) | 0.238 |
| RVEF (%) a | 53.5 ± 10.5 | 51.3 ± 13.4 | 0.725 | 54.1 ± 10.1 | 52.9 ± 12.9 | 0.725 | 37.7 ± 2.6 | 38.3 ± 7.5 | 0.965 | 42.3 ± 6.4 | 42.8 ± 8.1 | 0.578 |
| RVEF (%) | 57 (48–59) | 53 (43–53) | 0.725 | 57 (47–61) | 53 (43–63) | 0.965 | 37 (35–39) | 40 (37–43) | 0.286 | 41 (36–48) | 44 (39–49) | 0.558 |
| T2* (ms) | 36 (32–42) | 41 (34–46) | 0.279 | 37 (32–42) | 39 (34–46) | 0.292 | 52 (40–68) | 39 (34–45) | 0.292 | 42.3 (33–59) | 42.8 (37–46) | 0.695 |
| T1 mapping (ms) | 1082 (1064–1132) | 1078 (1067–1096) | 0.651 | 1073 (1031–1130) | 1082 (1067–1122) | 0.293 | 1116 (1087–1142) | 1079 (1050–1096) | 0.292 | 1101 (1064–1138) | 1081 (1050–1096) | 0.435 |
| Medical treatment | ||||||||||||
| Diuretics, n (%) | 16 (94) | 9 (90) | 0.631 | 18 (90) | 16 (89) | 0.656 | 4 (100) | 5 (83) | 0.600 | 7 (100) | 9 (90) | 0.588 |
| MRA, n (%) | 11 (65) | 4 (40) | 0.402 | 12 (60) | 7 (39) | 0.135 | 4 (100) | 1 (17) | 0.024 | 4 (57) | 3 (30) | 0.268 |
| Beta‐blockers, n (%) | 13 (76) | 10 (100) | 0.136 | 15 (75) | 17 (94) | 0.115 | 2 (50) | 5 (83) | 0.333 | 4 (70) | 9 (90) | 0.162 |
| ACEI or ARB, n (%) | 7 (41) | 5 (50) | 0.481 | 7 (35) | 9 (50) | 0.272 | 1 (25) | 4 (67) | 0.262 | 3 (43) | 7 (70) | 0.268 |
| Sacubitril/valsartan, n (%) | 4 (23) | 4 (40) | 0.316 | 5 (20) | 7 (39) | 0.284 | 2 (50) | 1 (17) | 0.333 | 2 (28) | 1 (10) | 0.360 |
ACEI, angiotensin‐converting enzyme inhibitor; AHF, acute heart failure; ARB, angiotensin II receptor blocker; CMR, cardiac magnetic resonance; eGFR, estimated glomerular filtration rate; HR, heart rate; IHD, ischaemic heart disease; LVEDVI, left ventricular end‐diastolic volume index; LVEF, left ventricular ejection fraction; LVESVI, left ventricular end‐systolic volume index; MRA, mineralocorticoid receptor antagonist; NT‐proBNP, N‐terminal pro‐brain natriuretic peptide; RVEF, right ventricular ejection fraction.
Values are expressed as median (inter‐quartile range); categorical variables are presented as percentages.
a
Values are expressed as mean ± standard deviation.