Table 1.
Baseline characteristics by HFimpEF status and treatment group in those with HFimpEF
| Patients with HFimpEF versus those with EF consistently over 40% | Treatment groups in patients with HFimpEF | |||||
|---|---|---|---|---|---|---|
| HFimpEF | EF consistently >40% | P | Dapagliflozin | Placebo | P | |
| n = 1,151 | n = 5,112 | |||||
| Age (years) | 70.1 ± 10.0 | 72.0 ± 9.4 | <0.001 | 69.9 ± 10.3 | 70.3 ± 9.8 | 0.58 |
| Male sex | 774 (67.2%) | 2,742 (53.6%) | <0.001 | 387 (67.7%) | 387 (66.8%) | 0.77 |
| Race | <0.001 | 0.10 | ||||
| White | 774 (67.2%) | 3,665 (71.7%) | 382 (66.8%) | 392 (67.7%) | ||
| Asian | 290 (25.2%) | 984 (19.2%) | 140 (24.5%) | 150 (25.9%) | ||
| Black or African American | 36 (3.1%) | 123 (2.4%) | 16 (2.8%) | 20 (3.5%) | ||
| American Indian or Alaska Native | 21 (1.8%) | 168 (3.3%) | 12 (2.1%) | 9 (1.6%) | ||
| Other | 30 (2.6%) | 172 (3.4%) | 22 (3.8%) | 8 (1.4%) | ||
| Geographical region | <0.001 | 0.64 | ||||
| Europe and Saudi Arabia | 482 (41.9%) | 2,523 (49.4%) | 236 (41.3%) | 246 (42.5%) | ||
| Asia | 284 (24.7%) | 942 (18.4%) | 136 (23.8%) | 148 (25.6%) | ||
| Latin America | 198 (17.2%) | 983 (19.2%) | 106 (18.5%) | 92 (15.9%) | ||
| North America | 187 (16.2%) | 664 (13.0%) | 94 (16.4%) | 93 (16.1%) | ||
| History of atrial fibrillation or flutter | 593 (51.5%) | 2,959 (57.9%) | <0.001 | 279 (48.8%) | 314 (54.2%) | 0.06 |
| Type 2 diabetes mellitus | 529 (46.0%) | 2,277 (44.5%) | 0.38 | 285 (49.8%) | 244 (42.1%) | 0.009 |
| History of myocardial infarction | 400 (34.8%) | 1,239 (24.2%) | <0.001 | 197 (34.4%) | 203 (35.1%) | 0.83 |
| History of HF hospitalization | 560 (48.7%) | 1,979 (38.7%) | <0.001 | 270 (47.2%) | 290 (50.1%) | 0.33 |
| Any coronary artery disease | 676 (58.7%) | 2,488 (48.7%) | <0.001 | 338 (59.1%) | 338 (58.4%) | 0.81 |
| Any atherosclerotic cardiovascular disease | 729 (63.3%) | 2,823 (55.2%) | <0.001 | 367 (64.2%) | 362 (62.5%) | 0.56 |
| Current smoker | 118 (10.3%) | 366 (7.2%) | 49 (8.6%) | 69 (11.9%) | 0.17 | |
| Baseline body mass index (kg m−2) | 29.4 ± 6.0 | 29.9 ± 6.1 | 0.008 | 29.7 ± 6.2 | 29.2 ± 5.7 | 0.16 |
| Time from diagnosis of HF to baseline | <0.001 | 0.62 | ||||
| 0–3 months | 61 (5.3%) | 507 (9.9%) | 31 (5.4%) | 30 (5.2%) | ||
| >3–6 months | 70 (6.1%) | 522 (10.2%) | 36 (6.3%) | 34 (5.9%) | ||
| >6–12 months | 114 (9.9%) | 728 (14.3%) | 63 (11.0%) | 51 (8.8%) | ||
| >1–2 years | 149 (12.9%) | 846 (16.6%) | 80 (14.0%) | 69 (11.9%) | ||
| >2–5 years | 350 (30.4%) | 1,219 (23.9%) | 168 (29.4%) | 182 (31.4%) | ||
| >5 years | 407 (35.4%) | 1,285 (25.2%) | 194 (33.9%) | 213 (36.8%) | ||
| NYHA class at baseline | 0.001 | 0.89 | ||||
| I | 0 (0%) | 1 (0%) | ||||
| II | 918 (79.8%) | 3,795 (74.2%) | 453 (79.2%) | 465 (80.3%) | ||
| III | 229 (19.9%) | 1,302 (25.5%) | 117 (20.5%) | 112 (19.3%) | ||
| IV | 4 (0.3%) | 14 (0.3%) | 2 (0.3%) | 2 (0.3%) | ||
| Baseline LVEF (%) | 50.5 ± 8.3 | 55.0 ± 8.7 | <0.001 | 50.3 ± 7.9 | 50.8 ± 8.7 | 0.29 |
| LVEF group | <0.001 | 0.47 | ||||
| ≤40 | 1 (0.1%) | 3 (0.1%) | 1 (0.2%) | 0 (0%) | ||
| ≥41–49 | 623 (54.1%) | 1,489 (29.1%) | 313 (54.7%) | 310 (53.5%) | ||
| 50–59 | 328 (28.5%) | 1,928 (37.7%) | 167 (29.2%) | 161 (27.8%) | ||
| ≥60 | 199 (17.3%) | 1,692 (33.1%) | 91 (15.9%) | 108 (18.7%) | ||
| Baseline NT-proBNP (pg ml−1) | 1,009 (623–1,728) | 1,012 (623–1,753) | 0.96 | 1,010 (627–1,812) | 1,007 (614–1,688) | 0.40 |
| Baseline ECG atrial fibrillation/flutter | 424 (36.8%) | 2,220 (43.4%) | <0.001 | 208 (36.4%) | 216 (37.3%) | 0.74 |
| Baseline systolic blood pressure (mm Hg) | 127.2 ± 16.6 | 128.5 ± 15.0 | 0.016 | 127.3 ± 16.8 | 127.2 ± 16.5 | 0.87 |
| Baseline eGFR (ml min−1 per 1.73 m2) | 61.9 ± 19.2 | 60.8 ± 19.1 | 0.10 | 61.9 ± 19.0 | 61.8 ± 19.3 | 0.90 |
| Medications | ||||||
| Loop diuretics | 883 (76.8%) | 3,928 (76.9%) | 0.96 | 446 (78.0%) | 437 (75.6%) | 0.34 |
| ACE inhibitor | 458 (39.8%) | 1,837 (35.9%) | 0.014 | 224 (39.2%) | 234 (40.5%) | 0.65 |
| ARB | 337 (29.3%) | 1,935 (37.9%) | <0.001 | 166 (29.0%) | 171 (29.6%) | 0.83 |
| Neprilysin inhibitor/ARB (ARNI) | 152 (13.2%) | 149 (2.9%) | <0.001 | 73 (12.8%) | 79 (13.7%) | 0.65 |
| Beta blocker | 991 (86.2%) | 4,186 (81.9%) | <0.001 | 486 (85.0%) | 505 (87.4%) | 0.24 |
| Mineralocorticoid receptor antagonist | 580 (50.4%) | 2,087 (40.8%) | <0.001 | 290 (50.7%) | 290 (50.2%) | 0.86 |
| ICD | 59 (5.1%) | 54 (1.1%) | <0.001 | 36 (6.3%) | 23 (4.0%) | 0.07 |
| ACE inhibitor, ARB, ARNI and beta blocker | 826 (72%) | 3,233 (63%) | <0.001 | 399 (69.8%) | 427 (73.9%) | 0.12 |
| ACE inhibitor, ARB, ARNI, beta blocker and mineralocorticoid receptor antagonist | 425 (37%) | 1,406 (28%) | <0.001 | 208 (36.4%) | 217 (37.5%) | 0.68 |