Table 1.
Historical control (2017–2018; n=198) |
Phase 1 (2019–2020; n=205) |
Phase 2 (2021–2022; n=195) |
P value | |
---|---|---|---|---|
Age (years) | 78 [69–86] | 80 [71–86] | 80 [72–86] | 0.541 |
Male sex | 109 (55.1) | 120 (58.5) | 113 (57.9) | 0.750 |
BMI (kg/m2) | 20.7 [18.8–22.6] | 20.8 [18.5–23.4] | 20.8 [18.6–23.1] | 0.913 |
SBP (mmHg) | 114 [102–129] | 111 [98–125] | 114 [102–130] | 0.141 |
Prior HF admission | 53 (26.8) | 61 (29.8) | 58 (29.7) | 0.769 |
NYHA Class III/IV | 23 (11.6) | 29 (14.1) | 35 (17.9) | 0.202 |
LVEF ≥50% | 89 (44.9) | 106 (51.7) | 87 (44.6) | 0.275 |
MAGGIC risk score | 25 [21–30] | 26 [22–31] | 26 [22–30] | 0.203 |
Hospital stay (days) | 21 [16–28] | 22 [17–29] | 21 [15–27] | 0.206 |
Comorbidity | ||||
CAD | 59 (29.8) | 62 (30.2) | 63 (32.3) | 0.856 |
Hypertension | 137 (69.2) | 140 (68.3) | 133 (68.2) | 0.981 |
Diabetes | 80 (40.4) | 74 (36.1) | 66 (33.8) | 0.392 |
Dyslipidemia | 85 (42.9) | 88 (42.9) | 65 (33.3) | 0.079 |
Atrial fibrillation | 85 (42.9) | 96 (46.8) | 81 (41.5) | 0.543 |
COPD | 10 (5.1) | 19 (9.3) | 18 (9.2) | 0.180 |
CVD | 34 (17.2) | 33 (16.1) | 39 (20.0) | 0.579 |
Medications | ||||
ACE-i/ARB | 133 (67.2) | 109 (53.2)* | 94 (48.2)* | <0.001 |
ARNI | 0 (0.0) | 1 (0.5) | 32 (16.4)* | <0.001 |
β-blocker | 146 (73.7) | 149 (72.7) | 148 (75.9) | 0.762 |
MRA | 68 (34.3) | 80 (39.0) | 87 (44.6) | 0.115 |
SGLT2 inhibitors | 1 (0.5) | 8 (3.9) | 47 (24.1)*,† | <0.001 |
Loop diuretics | 183 (92.4) | 192 (93.7) | 172 (88.2) | 0.134 |
Tolvaptan | 54 (27.3) | 58 (28.3) | 85 (43.6)*,† | 0.001 |
Device therapy | ||||
CRT/ICD | 9 (4.5) | 6 (2.9) | 9 (4.6) | 0.590 |
Laboratory values | ||||
Hemoglobin (g/dL) | 11.8 [10.4–13.4] | 11.8 [10.2–13.9] | 12.0 [10.5–13.7] | 0.806 |
Sodium (mEq/L) | 140 [137–141] | 139 [137–141] | 139 [137–141] | 0.079 |
BUN (mg/dL) | 30.7 [21.3–44.0] | 30.0 [21.0–47.1] | 27.7 [20.1–43.6] | 0.387 |
eGFR (mL/min/1.73 m2) | 41.8 [28.1–58.6] | 41.6 [26.6–55.5] | 42.7 [28.2–56.6] | 0.721 |
Albumin (g/dL) | 3.6 [3.3–3.9] | 3.6 [3.3–3.9] | 3.5 [3.1–3.7]† | 0.043 |
BNP (pg/mL; n=559) | 245.4 [113.8–479.4] | 242.7 [130.5–474.2] | 291.2 [161.1–517.4] | 0.115 |
Unless indicated otherwise, data are given as the median [interquartile range] or n (%). *P<0.05 compared with the historical control group; †P<0.05 compared with the Phase 1 group. ACE-i, angiotensin converting enzyme inhibitor; ARB, angiotensin II receptor blocker; ARNI, angiotensin receptor-neprilysin inhibitor; BMI, body mass index; BNP, B-type natriuretic peptide; BUN, blood urea nitrogen; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; CRT, cardiac resynchronized therapy; CVD, cerebrovascular disease; eGFR, estimated glomerular filtration rate; HF, heart failure; ICD, implantable cardioverter defibrillator; LVEF, left ventricular ejection fraction; MAGGIC, Meta-Analysis Global Group in Chronic Heart Failure; MRA, mineralocorticoid receptor antagonist; NYHA, New York Heart Association; SBP, systolic blood pressure; SGLT2, sodium-glucose cotransporter 2.