Table 1.
Characteristics of included trials and patients
| CHAMPION | GUIDE-HF | MONITOR-HF | |
|---|---|---|---|
| Enrolment period | 2007–2009 | 2018–2019 | 2019–2022 |
| Number of randomized patients | 550 | 1000 | 348 |
| Number of participating sites | 64 in 1 country (USA) | 140 in 2 countries (USA and Canada) | 25 in 1 country (the Netherlands) |
| Design | Single-blind randomized clinical trial, all patients received the device | Single-blind randomized clinical trial, all patients received the device | Open-label randomized clinical trial, allocation to CM or SC (no device) |
| Blinding | Patients only | Patients only | None |
| Key inclusion criteria | NYHA III | NYHA II–IV | NYHA III |
| HFH <12 months | HFH <12 months and/or elevated natriuretic peptides levels | HFH <12 months | |
| Treatment according to guidelines (GDMT and/or device) | Treatment according to guidelines (GDMT and/or device) | Treatment according to guidelines (GDMT and/or device) | |
| Key exclusion criteria | eGFR <25 | eGFR <25 | eGFR <25 |
| Recurrent PE/DVT | Intolerance to all neurohormonal antagonists | Recurrent PE/DVT | |
| CRT implantation <3 months | Current/recurrent PE/DVT | CRT implantation <3 months | |
| CRT <3 months | |||
| Mean follow-up time | 17.6 months | 10.8 months | 21.4 months |
| Follow-up period | Entire study (randomized access period) | Fixed 12-month time-point | Entire study |
| Primary clinical endpoint | Total HFH (first and recurrent events) | Composite of total HF events (first and recurrent, including urgent HF visits) and mortality at 12 months | Quality of life (KCCQ) |
| Secondary: total HFH (first and recurrent events), urgent visits, mortality | |||
| Adjudication of clinical endpoints | Independent and masked CEC | Independent and masked CEC | Independent and masked CEC |
| Reports on the following clinical endpoints | HFH | HFH | HFH |
| Death | Urgent visits with i.v. diuretics | Urgent visit with i.v. diuretics | |
| Death | Death | ||
| Subgroup data available on | Total HFH only | Composite of HFH, urgent HF visits, and death | Composite of HFH, urgent HF visits, and death |
| Control group | Sensor implant, but no monitoring | Sensor implant, but no monitoring | No sensor implanted |
| Baseline characteristics | Treatment (n = 270) | Control (n = 280) | Treatment (n = 497) | Control (n = 503) | Treatment (n = 176) | Control (n = 172) |
|---|---|---|---|---|---|---|
| Age, years (mean with SD, or median with IQR) | 61 (13) | 62 (13) | 71 (64–76) | 70 (64–77) | 69 (61–75) | 70 (61–75) |
| Male sex | 194 (72%) | 205 (73%) | 310 (62%) | 315 (63%) | 138 (78%) | 125 (73%) |
| NYHA functional class | ||||||
| II | 0 (0%) | 0 (0%) | 146 (29%) | 150 (30%) | 0 (0%) | 0 (0%) |
| III | 270 (100%) | 280 (100%) | 322 (65%) | 328 (65%) | 176 (100%) | 172 (100%) |
| IV | 0 (0%) | 0 (0%) | 29 (6%) | 25 (5%) | 0 (0%) | 0 (0%) |
| Median EF | N.A. | N.A. | 38% (25–55) | 40% (25–55) | 30% (23–40) | 30% (22–43) |
| LVEF | ||||||
| ≤40% | 222 (82%) | 234 (84%) | 273 (55%) | 258 (51%) | 134 (76%) | 127 (74%) |
| >40% | 48 (18%) | 46 (16%) | 224 (45%) | 245 (49%) | 42 (24%) | 45 (26%) |
| NT-proBNP (pg/mL) | N.A. | N.A. | 1480 (686–2743) | 1274 (661–2318) | 2377 (837–5153) | 1905 (691–4444) |
| eGFR, mean (SD), or median (IQR) | 60 (23) | 62 (23) | 51 (39–65) | 49 (38–65) | 48 (35–60) | 48 (38–63) |
| Ischaemic aetiology | 158 (59%) | 174 (62%) | 207 (42%) | 190 (38%) | 93 (53%) | 81 (47%) |
| GDMT (all patients) | ||||||
| ACEi/ARB/ARNI | 205 (76%) | 222 (79%) | 319 (64%) | 320 (64%) | 144 (82%) | 139 (81%) |
| ARNI | N.A. | N.A. | 145 (29%) | 139 (28%) | 81 (46%) | 81 (47%) |
| Beta-blocker | 243 (90%) | 256 (91%) | 444 (89%) | 442 (88%) | 150 (85%) | 142 (83%) |
| MRA | 117 (43%) | 114 (41%) | 237 (48%) | 216 (43%) | 143 (81%) | 144 (84%) |
| Diureticsa | 248 (92%) | 258 (92%) | 474 (95%) | 478 (95%) | 168 (96%) | 167 (97%) |
| SGLT2 inhibitor | N.A. | N.A. | 2 (<1%) | 2 (<1%) | 12 (7%) | 21 (12%) |
| Device therapy | ||||||
| ICD | 88 (33%) | 98 (35%) | 213 (43%) | 205 (41%) | 94 (53%) | 102 (59%) |
| CRT | 91 (34%) | 99 (35%) | 142 (29%) | 163 (32%) | 46 (26%) | 46 (27%) |
CEC, clinical event committee; ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin-receptor blocker; ARNI, angiotensin-receptor-neprilysin inhibitor; MRA, mineralocorticoid receptor antagonist; ICD, implantable cardioverter defibrillator; CRT, cardiac resynchronisation therapy; eGFR, estimated glomerular filtration rate; NYHA, New York Heart Association; EF, ejection fraction; LVEF, left ventricular ejection fraction; PE, pulmonary embolism; DVT, deep venous thrombosis; NT-proBNP, N-terminal pro-B-type natriuretic peptide; HF, heart failure; HFH, heart failure hospitalization; SGLT2, sodium-glucose cotransporter 2; SC, standard care; GDMT, guideline-directed medical therapy; i.v., intravenous; N.A., not available; SD, standard deviation; IQR, interquartile range; KCCQ, Kansas City Cardiomyopathy Questionnaire.
Loop diuretics for CHAMPION and MONITOR-HF, unknown for GUIDE-HF.