Table 1.
Demographics of remote patient management (RPM) and control group (UC) with regard to eGFR at randomization.
| eGFR < 60 ml/min/1.73 m2 | eGFR ≥60 ml/min/1.73 m2 | |||
|---|---|---|---|---|
| Group | RPM | UC | RPM | UC |
| N | 433 | 445 | 332 | 328 |
| Age (years) | 74 ± 8 | 74 ± 9 | 65 ± 11 | 66 ± 11 |
| Sex (male) | 283 (65.4%) | 288 (64.7%) | 250 (75.3%) | 249 (75.9%) |
| Living alone (%) | 113 (26.1%) | 125 (26.1%) | 100 (30.1%) | 97 (29.6%) |
| Living in a city area vs. rural area | ||||
| Rural | 260 (60.0%) | 249 (56.0%) | 197 (59.3%) | 209 (63.7%) |
| Urban | 173 (40.0%) | 196 (44.0%) | 135 (40.7%) | 119 (36.3%) |
| NYHA at Baseline | ||||
| I | 0 | 1 (0.2%) | 3 (0.9%) | 7 (2.1%) |
| II | 197 (45.5%) | 199 (44.7%) | 203 (61.1%) | 197 (60.1%) |
| III | 234 (54.0%) | 244 (54.8%) | 125 (37.7%) | 123 (37.5%) |
| IV | 2 (0.5%) | 1 (0.2%) | 1 (0.3%) | 1 (0.3%) |
| Left ventricular ejection fraction according to categorization to the study protocol | ||||
| ≤ 45% | 275 (63.5%) | 299 (67.2%) | 217 (65.4%) | 210 (64%) |
| >45% | 158 (36.5%) | 146 (32.8%) | 115 (34.6%) | 118 (36%) |
| Left ventricular ejection fraction according to categorization to current ESC guidelines post-hoc | ||||
| HFrEF ≤ 40% | 230 (53.1%) | 236 (53.0%) | 179 (53.9%) | 173 (52.7%) |
| HFmrEF 40–49% | 56 (12.9%) | 74 (16.6%) | 46 (13.9%) | 48 (14.6%) |
| HFpEF ≥ 50% | 147 (34.0%) | 135 (30.3%) | 107 (32.2%) | 107 (32.6%) |
| Days between discharge of last heart failure hospitalization and randomization | ||||
| ≤ 30 days | 118 (27.3%) | 117 (26.4%) | 80 (24.1%) | 75 (22.9%) |
| 31–90 days | 155 (35.8%) | 150 (33.8%) | 121 (36.4%) | 131 (39.9%) |
| >90 days | 160 (37.0%) | 177 (39.9%) | 131 (39.5%) | 122 (37.2%) |
| Weight at randomization (kg) | 83 (72–97) | 83 (72–96) | 87 (76–103) | 88 (77–102) |
| BMI (kg/m2) | 28.1 (24.5–33.1) | 28.7 (24.9–33.2) | 29.3 (25.7–33.6) | 29.3 (25.9–33.6) |
| Blood pressure (mmHg) | ||||
| Systolic | 125 (110–140) | 120 (110–140) | 125 (110–140) | 123 (110–136) |
| Diasystolic | 70 (65–80) | 70 (65–80) | 77.5 (70–80) | 75 (69–80) |
| Pulse (beats/min) | 71 (62–81) | 70 (61–79) | 70 (62–80) | 72 (61–82) |
| Primary cause of heart failure | ||||
| Ischemic cause (coronary artery disease/myocardial infarction) | 198 (45.7%) | 207 (46.5%) | 103 (31%) | 116 (35.4%) |
| Hypertension | 75 (17.3%) | 85 (19.1%) | 53 (16%) | 61 (18.6%) |
| Dilated cardiomyopathy | 67 (15.5%) | 84 (18.9%) | 109 (32.8%) | 87 (26.5%) |
| Other | 93 (21.5%) | 69 (15.5%) | 67 (20.2%) | 64 (19.5%) |
| Cardiovascular risk factors | ||||
| Smoking | ||||
| Unknown | 9 (2.1%) | 17 (3.8%) | 15 (4.5%) | 10 (3.0%) |
| Non-smoker | 240 (55.4%) | 233 (52.4%) | 138 (41.6%) | 152 (46.3%) |
| Former smoker | 157 (36.3%) | 174 (39.1%) | 129 (38.9%) | 130 (39.6%) |
| Smoker | 27 (6.2%) | 21 (4.7%) | 50 (15.1%) | 36 (11.0%) |
| Hyperlipidemia | ||||
| Unknown | 25 (5.8%) | 21 (4.7%) | 16 (4.8%) | 18 (5.5%) |
| No | 149 (34.4%) | 162 (36.4%) | 157 (47.3%) | 156 (47.6%) |
| Yes | 259 (59.8%) | 262 (58.9%) | 159 (47.9%) | 153 (46.6%) |
| Diabetes mellitus | 218 (50.3%) | 222 (49.9%) | 129 (38.9%) | 133 (40.5%) |
| Medical history | ||||
| Coronary revascularization (PCI) | 172 (39.7%) | 187 (42.0%) | 90 (27.1%) | 111 (33.8%) |
| Coronary artery bypass surgery | 87 (20.1%) | 94 (21.1%) | 47 (14.2%) | 51 (15.5%) |
| TAVI | 15 (3.5%) | 28 (6.3%) | 7 (2.1%) | 2 (0.6%) |
| Mitral-Clip | 21 (4.8%) | 26 (5.8%) | 5 (1.5%) | 8 (2.4%) |
| Cardiac surgery for valves | 48 (11.1%) | 41 (9.2%) | 38 (11.4%) | 30 (9.1%) |
| Implantable cardioverter defibrillator (ICD) | 134 (30.9%) | 154 (34.6%) | 90 (27.1%) | 80 (24.4%) |
| Cardiac resynchronization therapy (CRT) | 81 (18.7%) | 95 (21.3%) | 37 (11.1%) | 27 (8.2%) |
| Ablation of pulmonary veins | 38 (8.8%) | 32 (7.2%) | 33 (9.9%) | 20 (6.1%) |
| Laboratory measurements | ||||
| Hemoglobin (g/dl) | 12.9 (11.4–14.0) | 12.9 (11.7–14) | 13.7 (12.6–14.8) | 13.8 (12.8–14.9) |
| Serum sodium (mmol/l) | 140 (137–141) | 140 (138–142) | 139 (138–142) | 140 (138–142) |
| Serum potassium (mmol/l) | 4.5 (4.2–5.0) | 4.6 (4.2–5.0) | 4.5 (4.2–4.8) | 4.4 (4.1–4.7) |
| Serum creatinine (mg/dl) | 1.5 (1.3–1.8) | 1.5 (1.2–2.0) | 1.0 (0.9–1.1) | 1.0 (0.9–1.2) |
| eGFR CKD–EPI (ml/min/1.73 m2) | 42 (34–51) | 42 (31–51) | 79 (70–90) | 77 (67–88) |
| NT-proBNP (pg/ml) | 1,947 (973–4,487) | 1,943 (903–4,374) | 979 (395–1,809) | 1,035 (417–1,930) |
| Stratified by LVEF ≤ 45% vs. >45% | ||||
| NT-proBNP (pg/ml) in patients with LVEF ≤ 45% | 2,328 (1,254–5,389) | 2,398 (1,295–5,395) | 1,107 (479–2,183) | 1,118 (479–2,140) |
| NT-proBNP (pg/ml) in patients with LVEF >45% | 1,366 (641–2,617) | 1,117 (472–2,549) | 703 (208–1,257) | 853 (23–1,648) |
| Mid-regional pro-adrenomedullin (nmol/l) | 1.3 (1.0–1.8) | 1.3 (1.0–1.7) | 0.8 (0.7–1.0) | 0.9 (0.7–1.1) |
| Concomitant treatment | ||||
| ACE inhibitor or ARB | 347 (80.1%) | 365 (82.0%) | 281 (84.6%) | 276 (84.1%) |
| ARN inhibitor | 21 (4.8%) | 28 (6.3%) | 23 (6.9%) | 19 (5.8%) |
| Beta-blocker | 397 (91.7%) | 410 (92.1%) | 305 (91.9%) | 301 (91.8%) |
| Aldosterone antagonist | 221 (51.0%) | 221 (49.7%) | 220 (66.3%) | 184 (56.1%) |
| Loop diuretics | 421 (97.2%) | 431 (96.9%) | 296 (89.2%) | 290 (88.4%) |
| Thiazides | 126 (29.1%) | 119 (26.7%) | 65 (19.5%) | 66 (20.1%) |
| Other diuretics | 2 (0.5%) | 0 (0%) | 2 (0.6%) | 1 (0.3%) |
| Vitamin-K-antagonists | 170 (39.3%) | 175 (39.3%) | 95 (28.6%) | 97 (29.6%) |
| Antiplatelet therapy | 63 (14.5%) | 78 (17.5%) | 40 (12.0%) | 52 (15.9%) |
| DOAC | 117 (27%) | 117 (26.3%) | 88 (26.5%) | 91 (27.7%) |
| Platelet aggregation inhibitors | 146 (33.7%) | 145 (32.6%) | 120 (36.1%) | 122 (37.2%) |
| Lipid lowering | 267 (61.7%) | 271 (60.9%) | 189 (56.9%) | 182 (55.5%) |
| Insulin | 116 (26.8%) | 114 (25.6%) | 54 (16.3%) | 56 (17.1%) |
| Oral hypoglycemic | 114 (26.3%) | 95 (21.3%) | 92 (27.7%) | 90 (27.4%) |
| Calcium antagonist | 100 (23.1%) | 112 (25.2%) | 63 (19%) | 76 (23.2%) |
| Nitrate | 27 (6.2%) | 32 (7.2%) | 10 (3%) | 16 (4.9%) |
| Digitalis glycoside | 77 (17.8%) | 86 (19.3%) | 42 (12.7%) | 47 (14.3%) |
| Antiarrhythmic | 72 (16.6%) | 64 (14.4%) | 27 (8.1%) | 34 (10.4%) |
NYHA, New York heart association; HFrEF, Heart failure with reduced ejection fraction; HFmrEF, Heart failure with mildly reduced fraction; HFpEF, Heart failure with preserved ejection fraction; COPD, chronic obstructive pulmonary disease; ICD, implantable cardioverter-defibrillator; CRT, cardiac resynchronization therapy; TAVI, transcatheter aortic valve implantation; eGFR-CKDEPI, estimated glomerular filtration rate using the Chronic Kidney Disease Epidemiology Collaboration formula. Data are mean (SD) or n (%), and median (IQR) for all laboratory tests.