Table 1.
Baseline characteristics of PARADIGM‐HF patients by potassium categories at randomization
| Characteristics by K+ categories | ≤3.5 mmol/L | 3.6–4.0 mmol/L | 4.1–4.9 mmol/L | 5.0–5.4 mmol/L | ≥5.5 mmol/L | P‐value |
|---|---|---|---|---|---|---|
| n | 164 | 1069 | 5625 | 1168 | 197 | |
| Age, years, mean ± SD | 62.0 ± 13.0 | 61.7 ± 12.2 | 63.9 ± 11.3 | 65.4 ± 10.7 | 63.4 ± 10.8 | <0.001 |
| Age >70 years, n (%) | 42 (25.6) | 258 (24.1) | 1704 (30.3) | 400 (34.3) | 58 (29.4) | <0.001 |
| Female sex, n (%) | 39 (23.8) | 251 (23.5) | 1213 (21.6) | 251 (21.5) | 45 (22.8) | 0.65 |
| Race or ethnic group, n (%) | ||||||
| White | 70 (42.7) | 530 (49.6) | 3796 (67.5) | 858 (73.5) | 150 (76.1) | <0.001 |
| Black | 24 (14.6) | 95 (8.9) | 261 (4.6) | 37 (3.2) | 5 (2.5) | |
| Asian | 44 (26.8) | 294 (27.5) | 988 (17.6) | 152 (13.0) | 23 (11.7) | |
| Other | 26 (15.9) | 150 (14.0) | 580 (10.3) | 121 (10.4) | 19 (9.6) | |
| Region, n (%) | ||||||
| North America | 26 (15.9) | 132 (12.3) | 379 (6.7) | 45 (3.9) | 6 (3.0) | <0.001 |
| Latin America | 33 (20.1) | 227 (21.2) | 928 (16.5) | 188 (16.1) | 32 (16.2) | |
| Western Europe and other | 36 (22.0) | 179 (16.7) | 1436 (25.5) | 297 (25.4) | 38 (19.3) | |
| Central Europe | 27 (16.5) | 243 (22.7) | 1906 (33.9) | 490 (42.0) | 97 (49.2) | |
| Asia Pacific | 42 (25.6) | 288 (26.9) | 976 (17.4) | 148 (12.7) | 24 (12.2) | |
| Systolic blood pressure, mmHg, mean ± SD | 125.0 ± 17.0 | 122.5 ± 16.1 | 121.3 ± 15.3 | 120.1 ± 14.4 | 119.9 ± 13.3 | <0.001 |
| Heart rate, bpm, mean ± SD | 75.5 ± 13.3 | 73.5 ± 12.0 | 72.1 ± 11.9 | 72.2 ± 12.3 | 72.8 ± 12.8 | <0.001 |
| BMI, kg/m2, mean ± SD | 28.2 ± 7.5 | 27.9 ± 5.8 | 28.2 ± 5.4 | 28.3 ± 5.4 | 28.0 ± 5.7 | 0.42 |
| eGFR, mL/min/1.73 m2, mean ± SD | 72.4 ± 34.1 | 72.4 ± 20.8 | 68.0 ± 19.5 | 62.6 ± 18.5 | 60.3 ± 18.9 | <0.001 |
| eGFR ≤60, n (%) | 62 (37.8) | 312 (29.2) | 2083 (37.0) | 582 (49.8) | 108 (54.8) | <0.001 |
| Ischaemic cardiomyopathy, n (%) | 90 (54.9) | 588 (55.0) | 3347 (59.5) | 757 (64.8) | 135 (68.5) | <0.001 |
| Left ventricular ejection fraction, %, mean ± SD | 29.3 ± 6.4 | 29.4 ± 6.4 | 29.5 ± 6.2 | 29.6 ± 6.1 | 30.1 ± 6.4 | 0.59 |
| BNP, pg/mL, median (range) | 311 (184–717) | 291 (169–611) | 243 (150–447) | 260 (160–468) | 271 (171–530) | <0.001 |
| BNP in AF+, median (range) | 360 (184–692) | 291 (181–544) | 245 (157–434) | 251 (159–453) | 273 (185–588) | <0.001 |
| BNP in AF‐, median (range) | 302 (183–783) | 291 (161–643) | 241 (145–455) | 269 (160–471) | 267 (153–491) | <0.001 |
| NT‐proBNP, pg/mL, median (range) | 2476 (1199–5093) | 1884 (941–4165) | 1541 (862–3024) | 1705 (946–3380) | 1747 (926–3392) | <0.001 |
| NT‐proBNP in AF+, median (range) | 3019 (1561–6083) | 2131 (1114–4520) | 1812 (1059–3420) | 1961 (1172–3611) | 2155 (1412–4781) | <0.001 |
| NT‐proBNP in AF‐, median (range) | 2276 (1090–4565) | 1759 (847–3863) | 1383 (804–2782) | 1532 (856–3161) | 1547 (747–2424) | <0.001 |
| NYHA functional class, n (%) | ||||||
| I | 6 (3.7) | 50 (4.7) | 270 (4.8) | 46 (4.0) | 9 (4.6) | 0.37 |
| II | 120 (73.2) | 774 (72.5) | 3971 (70.7) | 801 (68.8) | 131 (67.2) | |
| III | 36 (22.0) | 235 (22.0) | 1342 (23.9) | 306 (26.3) | 55 (28.2) | |
| IV | 2 (1.2) | 9 (0.8) | 36 (0.6) | 11 (0.9) | 0 (0.0) | |
| Hypertension, n (%) | 116 (70.7) | 758 (70.9) | 3928 (69.8) | 866 (74.1) | 140 (71.1) | 0.068 |
| Diabetes, n (%) | 54 (32.9) | 334 (31.2) | 1915 (34.0) | 458 (39.2) | 79 (40.1) | <0.001 |
| Atrial fibrillation, n (%) | 60 (36.6) | 360 (33.7) | 2075 (36.9) | 445 (38.1) | 82 (41.6) | 0.12 |
| Prior HF hospitalization, n (%) | 119 (72.6) | 669 (62.6) | 3542 (63.0) | 715 (61.2) | 119 (60.4) | 0.074 |
| Prior MI, n (%) | 61 (37.2) | 411 (38.4) | 2420 (43.0) | 554 (47.4) | 99 (50.3) | <0.001 |
| Prior stroke, n (%) | 15 (9.1) | 77 (7.2) | 509 (9.0) | 95 (8.1) | 11 (5.6) | 0.15 |
| Prior use of ACEi, n (%) | 115 (70.1) | 772 (72.2) | 4395 (78.1) | 945 (80.9) | 162 (82.2) | <0.001 |
| Prior use of ARB, n (%) | 51 (31.1) | 298 (27.9) | 1249 (22.2) | 225 (19.3) | 36 (18.3) | <0.001 |
| Diuretic, n (%) | 141 (86.0) | 892 (83.4) | 4482 (79.7) | 920 (78.8) | 156 (79.2) | 0.011 |
| Digoxin, n (%) | 50 (30.5) | 334 (31.2) | 1718 (30.5) | 341 (29.2) | 57 (28.9) | 0.84 |
| Beta‐blocker, n (%) | 154 (93.9) | 968 (90.6) | 5247 (93.3) | 1098 (94.0) | 182 (92.4) | 0.013 |
| MRA, n (%) | 75 (45.7) | 509 (47.6) | 3179 (56.5) | 704 (60.3) | 117 (59.4) | <0.001 |
| ICD (incl. CRT‐D), n (%) | 18 (11.0) | 139 (13.0) | 868 (15.4) | 176 (15.1) | 18 (9.1) | 0.022 |
| CRT, n (%) | 9 (5.5) | 66 (6.2) | 398 (7.1) | 83 (7.1) | 9 (4.6) | 0.49 |
| Randomized to sacubitril–valsartan, n (%) | 84 (51.2) | 527 (49.3) | 2787 (49.5) | 605 (51.8) | 94 (47.7) | 0.63 |
ACEi, angiotensin‐converting enzyme inhibitor; AF, atrial fibrillation; ARB, angiotensin receptor blocker; BMI, body mass index; BNP, brain natriuretic peptide; CRT, cardiac resynchronization therapy; eGFR, estimated glomerular filtration rate; HF, heart failure; ICD, implantable cardioverter‐defibrillator; MI, myocardial infarction; MRA, mineralocorticoid receptor antagonist; NT‐proBNP, N‐terminal pro brain natriuretic peptide; SD, standard deviation.