Table 2.
Demographics of the whole cohort, impaired (eGFR < 60 ml/min/1.73 m2), and normal (eGFR ≥ 60 ml/min/1.73 m2).
| All | eGFR < 60 ml/min/1.73 m2 | eGFR ≥ 60 ml/min/1.73 m2 | |
|---|---|---|---|
| N | 1,538 | 878 | 660 |
| Age (years) | 70 ± 11 | 74 ± 8 | 66 ± 11 |
| Sex (% male) | 1,070 (69.6%) | 571 (65.0%) | 499 (75.6%) |
| Living alone (%) | 435 (28.3%) | 238 (27.1%) | 197 (29.8%) |
| Living in a city are vs. rural area | |||
| Rural | 915 (59.5%) | 509 (58.0%) | 406 (61.5%) |
| Urban | 623 (40.5%) | 369 (42.0%) | 254 (38.5%) |
| NYHA at Baseline (%) | |||
| I | 11 (0.7%) | 1 (0.1%) | 10 (1.5%) |
| II | 796 (51.8%) | 396 (45.1%) | 400 (60.6%) |
| III | 726 (47.2%) | 478 (54.4%) | 248 (37.6%) |
| IV | 5 (0.3%) | 3 (0.3%) | 2 (0.3%) |
| Left ventricular ejection fraction according to categorization to the study protocol | |||
| ≤ 45% | 1,001 (65.1%) | 574 (65.4%) | 427 (64.7%) |
| >45% | 537 (34.9% | 304 (34.6%) | 233 (35.3%) |
| Left ventricular ejection fraction according to categorization to current ESC guidelines post-hoc | |||
| HFrEF ≤ 40% | 818 (53.2%) | 466 (53.1%) | 352 (53.5%) |
| HFmrEF 40–49% | 224 (14.6%) | 130 (14.8%) | 94 (14.3%) |
| HFpEF ≥50% | 496 (32.2%) | 282 (32.1%) | 214 (32.4%) |
| Days between discharge of last heart failure hospitalization and randomization | |||
| ≤ 30 days | 390 (25.4%) | 235 (26.8%) | 155 (23.5%) |
| 31–90 days | 557 (36.2%) | 305 (34.7%) | 252 (38.2%) |
| >90 days | 590 (38.4%) | 337 (38.4%) | 253 (38.3%) |
| Weight at randomization (kg) | 87 ± 20 | 85 ± 19.2 | 90 ± 20.6 |
| BMI (kg/m2) | 29.7 ± 6.2 | 29.3 ± 6.1 | 30.1 ± 6.4 |
| Blood pressure (mmHg) | |||
| Systolic | 125 ± 19.4 | 125 ± 19.6 | 126 ± 19.0 |
| Diastolic | 74 ± 11.3 | 73 ± 11.5 | 75 ± 11.0 |
| Pulse (beats/min) | 72 ± 14.0 | 72 ± 13.6 | 73 ± 14.5 |
| Primary cause of heart failure | |||
| Ischemic cause (coronary artery disease/myocardial infarction) | 624 (40.6%) | 405 (46.1%) | 219 (33.2%) |
| Hypertension | 274 (17.8%) | 160 (18.2%) | 114 (17.3%) |
| Dilated cardiomyopathy | 347 (22.6%) | 151 (17.2%) | 196 (29.7%) |
| Other | 293 (19.1%) | 162 (18.5%) | 131 (19.8%) |
| Cardiovascular risk factors | |||
| Smoking | |||
| Unknown | 51 (3.3%) | 26 (3.0%) | 25 (3.8%) |
| Non-smoker | 763 (49.6%) | 473 (53.9%) | 290 (43.9%) |
| Former smoker | 590 (38.4%) | 331 (37.7%) | 259 (39.2%) |
| Smoker | 134 (8.7%) | 48 (5.5%) | 86 (13.0%) |
| Hyperlipidemia | |||
| Unknown | 80 (5.2) | 46 (5.2%) | 34 (5.2%) |
| No | 624 (40.6%) | 311 (35.4%) | 313 (47.5%) |
| Yes | 833 (54.2%) | 521 (59.3%) | 312 (47.3%) |
| Diabetes mellitus (%) | 702 (45.6%) | 440 (50.1%) | 262 (39.7%) |
| Medical history | |||
| Coronary revascularization (PCI) | 560 (36.4%) | 359 (40.9%) | 453 (30.5%) |
| Coronary artery bypass surgery | 279 (18.1%) | 181 (20.6%) | 98 (14.8%) |
| TAVI | 52 (3.4%) | 43 (4.9%) | 9 (1.4%) |
| Mitral-Clip | 60 (3.9%) | 47 (5.4%) | 13 (2.0%) |
| Cardiac surgery for valves | 157 (10.2%) | 89 (10.1%) | 68 (10.3%) |
| Implantable cardioverter defibrillator (ICD) | 458 (29.8%) | 288 (32.8%) | 170 (25.8%) |
| Cardiac resynchronization therapy (CRT) | 240 (15.6%) | 176 (20.0%) | 64 (9.7%) |
| Ablation of pulmonary veins | 123 (8.0%) | 70 (8.0%) | 53 (8.0%) |
| Laboratory measurements | |||
| Hemoglobin (g/dl) | 13.2 (12.1–14) | 12.9 (11.6–14.0) | 13.8 (12.7–14.8) |
| Serum sodium (mmol/l) | 140 (137–142) | 140 (137–142) | 140 (138–142) |
| Serum potassium (mmol/L) | 4.5 (4.2–4.9) | 4.8 (4.2–5.0) | 4.4 (4.2–4.8) |
| Serum creatinine (mg/dl) | 1.4 (1–1.6) | 1.5 (1.2–1.9) | 1 (0.9–1.1) |
| eGFR CKD–EPI (ml/min/1.73 m2) | 55 (40–75) | 42 (33–51) | 78 (69–89) |
| NT-proBNP (pg/ml) | 1,436 (605–3,100) | 1,945 (930–4,413) | 994 (414–1,884) |
| Stratified by LVEF ≤ 45% vs. >45% | |||
| NT-proBNP (pg/ml) in patients with LVEF >45 (n = 537) | 1,749 (786–3,791) | 1,255 (555–2,592) | 782 (239–1,489) |
| NT-proBNP (pg/ml) in patients with LVEF ≤ 45 (n = 1,001) | 1,037 (416–2,030) | 2,373 (1,279–5,384) | 1,107 (479–2,171) |
| Mid-regional pro-adrenomedullin (nmol/L) | 1.1 (0.8–1.5) | 1.3 (1.0–1.8) | 0.8 (0.7–1.0) |
| Concomitant treatment | |||
| ACE inhibitor or ARB | 1,269 (82.5%) | 712 (81.1%) | 557 (84.4%) |
| ARN inhibitor | 91 (5.9%) | 49 (5.6%) | 42 (6.4%) |
| Beta-blocker | 1,413 (91.9%) | 807 (91.9%) | 606 (91.8%) |
| Aldosterone antagonist | 846 (55.0%) | 442 (50.3%) | 404 (61.2%) |
| Loop diuretics | 1,438 (93.5%) | 852 (97.0%) | 586 (88.8%) |
| Thiazides | 376 (24.4%) | 245 (27.9%) | 131 (19.8%) |
| Other diuretics | 5 (0.3%) | 2 (0.2%) | 3 (0.5%) |
| Vitamin-K-antagonists | 537 (34.9%) | 345 (39.3%) | 192 (29.1%) |
| Antiplatelet therapy | 233 (15.1%) | 141 (16.1%) | 92 (13.9%) |
| DOAC | 413 (26.9%) | 234 (26.4%) | 179 (27.1%) |
| Platelet aggregation inhibitors | 533 (34.7%) | 291 (33.1%) | 242 (36.7%) |
| Lipid lowering | 909 (59.1%) | 538 (61.3%) | 371 (56.2%) |
| Insulin | 340 (22.1%) | 230 (26.2%) | 110 (16.7%) |
| Oral hypoglycemic | 391 (25.4%) | 209 (23.8%) | 182 (27.6%) |
| Calcium antagonist | 351 (22.8%) | 212 (24.1%) | 139 (21.1%) |
| Nitrate | 85 (5.5%) | 59 (6.7%) | 26 (3.9%) |
| Digitalis glycoside | 252 (16.4%) | 163 (18.6%) | 89 (13.5%) |
| Antiarrhythmic | 197 (12.8%) | 136 (15.5%) | 61 (9.2%) |
Data are mean (SD) or number of patients (%), median and IQR (inter-quartile range) for laboratory measurements. ACE, angiotensin-converting enzyme; ARB, angiotensin-receptor blocker; ARN, angiotensin receptor-neprilysin; CRT, cardiac resynchronisation therapy; DOAC, direct oral anticoagulants; eGFR, estimated glomerular filtration rate using the Chronic Kidney Disease Epidemiology Collaboration formula; HFrEF, Heart failure with reduced ejection fraction; HFmrEF, Heart failure with mildly reduced fraction; HFpEF, Heart failure with preserved ejection fraction; ICD, implantable cardioverter-defibrillator; LVEF, left ventricular ejection fraction; NT-proBNP, N-terminal-pro-B-type natriuretic peptide; NYHA, New York Heart Association; TAVI, transcatheter aortic valve implantation.