Table 1. Baseline clinical characteristic of patients included in recent HFrEF trials.
| Variables | PARADIGM-HF (n=8,399) | PIONEER-HF (n=881) | DAPA-HF (n=4,744) | EMPEROR-Reduced (n=3,730) | VICTORIA (n=5,050) | GALACTIC-HF (n=8,256) | |
|---|---|---|---|---|---|---|---|
| Inclusion criteria | |||||||
| LVEF (%) | ≤40 (≤35 after year 2010) | ≤40 | ≤40 | ≤40 | <45 | ≤35 | |
| Natriuretic peptides, pg/mL – sinus rhythm | If no HF hospitalizations in past 12 months: BNP ≥150 or NT-proBNP ≥600 | BNP ≥400 or NT-proBNP ≥1,600 | If no HF hospitalizations in past 12 months: NT-proBNP ≥600 pg/mL | EF ≥36% to ≤40%: NT-proBNP ≥2,500; EF ≥31% to ≤35%: NT-proBNP ≥1,000; EF≤ 30%: ≥600; EF ≤40% and HF hospitalization in past 12 months: NT-proBNP ≥600 | BNP≥300 or NT-proBNP ≥1,000 | BNP≥125 or NT-proBNP ≥400 | |
| If a HF hospitalization in past 12 months: BNP ≥100 or NT-proBNP ≥400 | If HF hospitalizations in past 12 months or NT-proBNP ≥400 pg/mL | ||||||
| Natriuretic peptides, pg/mL – AF/F | Not specified | Not specified | NT-proBNP ≥900 | EF ≥36% to ≤40%: ≥5,000; EF ≥31% to ≤35%: NT-proBNP ≥2,000; EF ≤30%: NT-proBNP ≥1,200; EF ≤40% and HF hospitalization in past 12 months: NT-proBNP ≥1,200 | BNP ≥500 or NT-proBNP ≥1,600 | BNP ≥375 or NT-proBNP ≥1,200 | |
| SBP (mmHg) | ≥95 | >100 | ≥95 | >100 | ≥100 | ≥85 | |
| eGFR (mL/min/1.73 m2) | ≥30 | ≥30 | ≥30 | >20 | ≥15 | ≥20 | |
| Prior HF hosp. (or equiv.) required? | No | No | No | No | Yes (100%) | Yes (100%) | |
| In-patients included? | No | Yes | No | No | Yes | Yes (25%) | |
| Baseline patient characteristics | |||||||
| Age (years) | 63.8±11.5 | 61.0±14.0 | 66.2±11.0 | 67.2±10.8 | 67.5±12.2 | 64.5±11.3 | |
| Female, % | 21.0 | 25.7 | 23.8 | 23.5 | 24.0 | 21.2 | |
| NYHA class III/IV, % | 23.9 | 73.1 | 32.3 | 24.9 | 41.4 | 46.7 | |
| LVEF, % | 29.6±6.1 | 24.0±6.0 | 31.2±6.7 | 27.7±6.0 | 29.0±8.3 | 26.6±6.3 | |
| Prior HF hosp. (or equiv.), % | 62.3 | 67.7 | 47.4 | 31.0 | 100.0 | 100.0 | |
| NT-proBNP, pg/mL median (IQR) | 1,631 (885–3,154) | 4,821 (3,109–8,767) | 1,428 (857–2,655) | 1,887 (1,077–3,429) | 2,803.5 (1,572–5,380) | 1,977 (980–4,061) | |
| Atrial fibrillation, % | 36.2 | 33.4 | 38.6 | 35.6 | 43.5 | 27.8 | |
| Hypertension, % | 70.9 | 87.3 | Not listed | 72.4 | 48.6 | Not listed | |
| Diabetes, % | 34.7 | 18.0 | 41.8 | 49.8 | 48.6 | 40.1 | |
| Myocardial infarction, % | 43.4 | 6.1 | Not listed | Not listed | Not listed | Not listed | |
| Ischaemic cardiomyopathy, % | 59.9 | Not listed | 55.5 | 52.8 | 59.8 | 53.2 | |
| Stroke, % | 8.5 | 10.0 | Not listed | Not listed | 11.2 | Not listed | |
| eGFR, mL/min/1.73 m2 (SD or IQR) | 68.0 | 58.4 (47.5–71.5) | 66.0±19.6 | 61.8±21.7 | 61.3±27 | 58.8 (44.3–74.3) | |
| Beta-blocker, % | 94.0 | 59.5 | 96.0 | 94.7 | 93.0 | 94.2 | |
| ACEI, % | 78.0 | 47.3* | 56.1 | 70.5* | 73.3* | 87.0† | |
| ARB, % | 22.2 | - | 28.4 | - | - | - | |
| MRA, % | 54.2 | 10.9 | 71.0 | 70.1 | 69.3 | 77.6 | |
| ARNI, % | Not applicable | Not applicable | 10.5 | 18.3 | 14.3 | 19.9 | |
| Diuretic, % | 80.3 | 59.5 | 93.4 | Not listed | Not listed | Not listed | |
| Digitalis, % | 29.2 | 9.3 | 18.8 | Not listed | Not listed | Not listed | |
Medical history and comorbidities data refers to investigated drug group; *ACEI or ARB, †ACEI or ARB or ARNI.
LVEF = left ventricular ejection fraction; HF = heart failure; BNP = brain natriuretic peptide; NT-proBNP = N-terminal pro-brain natriuretic peptide; AF/F = atrial fibrillation/flutter; SBP = systolic blood pressure; eGFR = estimated glomerular filtration rate; NYHA = New York Heart Association; IQR = interquartile range; SD = standard deviation; ACEI = angiotensin converting enzyme inhibitors; ARB = angiotensin receptor blockers; MRA = mineralocorticoid receptor antagonists; ARNI = angiotensin receptor-neprilysin inhibitor.