Table.
Baseline Characteristics of Patients in 6 Selected Randomized Controlled Trials (RCTs)
| Characteristic | RCTs | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PARADIGM-HF | DAPA-HF | EMPEROR-Reduced | PARAGON-HF | DELIVER | EMPEROR-Preserved | |||||||||||||
| Eligible | Ineligible | P value | Eligible | Ineligible | P value | Eligible | Ineligible | P value | Eligible | Ineligible | P value | Eligible | Ineligible | P value | Eligible | Ineligible | P value | |
| n (%) | 116 (51.6) | 109 (48.4) | 143 (63.6) | 82 (36.4) | 129 (57.3) | 96 (42.7) | 233 (42.1) | 321 (57.9) | 427 (67.7) | 204 (32.3) | 433 (68.6) | 198 (31.4) | ||||||
| Age, years | 77.5 (70.0–86.0) |
79.0 (70.0–87.0) |
0.63 | 77.0 (70.0–85.0) |
81.0 (69.0–87.0) |
0.39 | 78.0 (70.0–86.0) |
79.0 (70.0–86.0) |
0.62 | 82.0 (74.0–87.0) |
82.0 (74.0–88.0) |
0.64 | 82.0 (74.0–87.0) |
82.0 (73.5–87.0) |
0.93 | 82.0 (74.0–88.0) |
81.0 (73.0–87.0) |
0.48 |
| Female sex, n (%) | 25 (21.6) | 41 (37.6) | <0.05 | 35 (24.5) | 31 (37.8) | <0.05 | 29 (22.5) | 37 (38.5) | <0.05 | 119 (51.1) | 147 (45.8) | 0.22 | 203 (47.5) | 88 (43.1) | 0.30 | 203 (46.9) | 88 (44.4) | 0.57 |
| BMI, kg/m2 | 23.0 (20.5–25.0) |
20.7 (18.3–23.9) |
<0.05 | 22.5 (19.6–24.8) |
21.0 (18.4–24.0) |
0.06 | 23.0 (20.4–25.1) |
20.6 (18.2–23.2) |
<0.05 | 22.4 (20.2–24.7) |
21.4 (18.9–24.0) |
<0.05 | 21.8 (19.2–24.1) |
22.0 (19.6–24.5) |
0.22 | 22.0 (19.6–24.3) |
21.2 (18.7–24.0) |
0.06 |
| SBP, mmHg | 119 (109–131) |
100 (93.8–121) |
<0.05 | 115 (104–128) |
108 (92–124) |
<0.05 | 119 (110–130) |
98.0 (92.0–118) |
<0.05 | 131 (120–143) |
115 (103–136) |
<0.05 | 123 (112–138) |
119 (100–142) |
<0.05 | 124 (113–138) |
114 (96.0–141) |
<0.05 |
| Heart rate, beats/min | 71.0 (60.5–80.0) |
73.0 (65.0–83.3) |
0.20 | 71.0 (61.3–82.0) |
73.5 (65.0–83.0) |
0.42 | 71.0 (60.0–80.0) |
74.0 (66.0–84.5) |
<0.05 | 69.0 (61.0–79.0) |
71.0 (63.0–79.0) |
0.47 | 70.0 (62.0–79.0) |
72.0 (63.0–79.0) |
0.54 | 70.0 (62.0–79.0) |
72.0 (64.8–79.0) |
0.32 |
| Hemoglobin, g/dL | 13.3 (11.8–14.8) |
12.0 (10.5–13.9) |
<0.05 | 13.1 (11.7–14.6) |
12.0 (10.5–14.0) |
<0.05 | 13.3 (11.8–14.7) |
11.9 (10.1–13.8) |
<0.05 | 12.5 (11.5–13.5) |
11.3 (9.70–12.6) |
<0.05 | 12.1 (10.9–13.4) |
11.4 (9.75–12.6) |
<0.05 | 12.2 (11.0–13.5) |
11.1 (9.40–12.5) |
<0.05 |
| Potassium, mEq/L | 4.00 (3.80–4.30) |
4.20 (3.80–4.60) |
<0.05 | 4.00 (3.80–4.38) |
4.20 (3.80–4.60) |
<0.05 | 4.10 (3.80–4.40) |
4.20 (3.70–4.55) |
0.48 | 4.10 (3.80–4.40) |
4.10 (3.90–4.43) |
0.15 | 4.10 (3.80–4.40) |
4.10 (3.80–4.50) |
0.43 | 4.10 (3.80–4.40) |
4.10 (3.80–4.50) |
0.96 |
| Albumin, g/dL | 3.80 (3.50–4.10) |
3.60 (3.20–3.90) |
<0.05 | 3.70 (3.40–4.10) |
3.60 (3.20–4.00) |
<0.05 | 3.80 (3.50–4.10) |
3.50 (3.20–3.90) |
<0.05 | 3.90 (3.50–4.10) |
3.50 (3.10–3.90) |
<0.05 | 3.70 (3.30–4.10) |
3.50 (3.10–3.80) |
<0.05 | 3.80 (3.40–4.10) |
3.40 (3.00–3.73) |
<0.05 |
| Serum creatinine, mg/dL | 1.00 (0.85–1.26) |
1.36 (0.98–2.24) |
<0.05 | 1.03 (0.85–1.26) |
1.65 (1.06–2.56) |
<0.05 | 1.08 (0.85–1.33) |
1.27 (0.92–2.21) |
<0.05 | 0.92 (0.75–1.12) |
1.29 (0.96–2.28) |
<0.05 | 0.98 (0.78–1.21) |
1.82 (1.06–4.10) |
<0.05 | 0.99 (0.80–1.32) |
1.58 (0.97–4.40) |
<0.05 |
| eGFR, mL/min/1.73 m2 | 52.0 (42.0–63.5) |
35.0 (20.0–53.0) |
<0.05 | 50.0 (41.3–62.0) |
27.5 (17.0–52.0) |
<0.05 | 49.0 (37.0–62.3) |
40.0 (19.0–55.0) |
<0.05 | 52.0 (42.0–64.0) |
33.0 (20.0–54.0) |
<0.05 | 49.0 (39.0–63.0) |
22.0 (11.0–47.0) |
<0.05 | 48.0 (36.0–61.0) |
29.5 (10.0–55.0) |
<0.05 |
| Clinical features of HF | ||||||||||||||||||
| Ischemic cause, n (%) | 52 (44.8) | 42 (38.5) | 0.34 | 62 (43.4) | 32 (39.0) | 0.53 | 60 (46.5) | 34 (35.4) | 0.10 | 62 (26.6) | 80 (24.9) | 0.65 | 108 (25.3) | 61 (29.9) | 0.22 | 117 (27.0) | 52 (26.3) | 0.84 |
| LVEF, % | 32.0 (27.0–37.0) |
33.0 (28.4–36.0) |
0.87 | 33.0 (29.0–37.0) |
31.0 (26.0–36.0) |
<0.05 | 33.0 (28.0–37.2) |
31.5 (27.0–35.9) |
0.06 | 60.0 (54.0–66.0) |
58.0 (52.0–63.0) |
<0.05 | 57.6 (51.0–64.0) |
57.0 (49.6–63) |
0.55 | 57.3 (50.2–64.0) |
57.0 (50.0–63.0) |
0.86 |
| BNP, pg/mL | 284 (133–630) |
466 (246–874) |
<0.05 | 302 (138–577) |
524 (216–1,085) |
<0.05 | 275 (129–627) |
500 (274–902) |
<0.05 | 173 (82.3–307) |
223 (94.7–433) |
<0.05 | 179 (82.4–335) |
263 (141–555) |
<0.05 | 187 (85.1–348) |
241 (124–528) |
<0.05 |
| Medical history, n (%) | ||||||||||||||||||
| Diabetes | 50 (43.1) | 44 (40.4) | 0.68 | 65 (45.5) | 29 (35.4) | 0.14 | 54 (41.9) | 40 (41.7) | 0.98 | 72 (30.9) | 104 (32.4) | 0.71 | 118 (27.6) | 80 (39.2) | <0.05 | 122 (28.2) | 76 (38.4) | <0.05 |
| Hypertension | 87 (75.0) | 67 (61.5) | <0.05 | 104 (72.7) | 50 (61.0) | 0.07 | 93 (72.1) | 61 (63.5) | 0.17 | 184 (79.0) | 234 (72.9) | 0.10 | 315 (73.8) | 157 (77.0) | 0.39 | 327 (75.5) | 145 (73.2) | 0.54 |
| Atrial fibrillation | 48 (41.4) | 59 (54.1) | 0.06 | 65 (45.5) | 42 (51.2) | 0.41 | 55 (42.6) | 52 (54.2) | 0.09 | 94 (40.3) | 154 (48.0) | 0.07 | 198 (46.4) | 90 (44.1) | 0.60 | 205 (47.3) | 83 (41.9) | 0.20 |
| Hospitalization for HF | 80 (69.0) | 93 (85.3) | <0.05 | 102 (71.3) | 71 (86.6) | <0.05 | 91 (70.5) | 82 (85.4) | <0.05 | 112 (48.1) | 227 (70.7) | <0.05 | 244 (57.1) | 147 (72.1) | <0.05 | 246 (56.8) | 145 (73.2) | <0.05 |
| Treatment, n (%) | ||||||||||||||||||
| ACE-Is or ARBs | 89 (76.7) | 74 (67.9) | 0.14 | 106 (74.1) | 57 (69.5) | 0.46 | 101 (78.3) | 62 (64.6) | <0.05 | 155 (66.5) | 195 (60.7) | 0.16 | 288 (67.4) | 113 (55.4) | <0.05 | 292 (67.4) | 109 (55.1) | <0.05 |
| β-blockers | 104 (89.7) | 95 (87.2) | 0.56 | 129 (90.2) | 70 (85.4) | 0.28 | 116 (89.9) | 83 (86.5) | 0.42 | 156 (67.0) | 209 (65.1) | 0.65 | 287 (67.2) | 135 (66.2) | 0.80 | 296 (68.4) | 126 (63.6) | 0.24 |
| MRAs | 67 (57.8) | 61 (56.0) | 0.79 | 84 (58.7) | 44 (53.7) | 0.46 | 75 (58.1) | 53 (55.2) | 0.66 | 82 (35.2) | 116 (36.1) | 0.82 | 175 (41.0) | 67 (32.8) | <0.05 | 169 (39.0) | 73 (36.9) | 0.60 |
| Diuretics | 78 (76.7) | 88 (80.7) | 0.46 | 114 (79.7) | 63 (76.8) | 0.61 | 100 (77.5) | 77 (80.2) | 0.63 | 135 (57.9) | 227 (70.7) | <0.05 | 279 (65.3) | 142 (69.6) | 0.29 | 289 (66.7) | 132 (66.7) | 0.98 |
ACE-I, angiotensin-converting enzyme inhibitor; ARB, angiotensin-receptor blocker; BMI, body mass index; BNP, B-type natriuretic peptide; eGFR, estimated glomerular filtration rate; HF, heart failure; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid antagonist; RCT, randomized controlled trial; SBP, systolic blood pressure.