Table 1.
Baseline characteristics of patients from the pooled STEP-HFpEF and STEP-HFpEF-DM trials, stratified by baseline diuretic use
| Baseline characteristicsa | Diuretic group | P-value | ||||
|---|---|---|---|---|---|---|
| No diuretic (n = 220) | Non-loop diuretic only (n = 223) | Loop diuretic, dose < 40 mg/day (n = 219) | Loop diuretic, dose = 40 mg/day (n = 309) | Loop diuretic, dose > 40 mg/day (n = 174) | ||
| Female sex, n (%) | 114 (51.8) | 108 (48.4) | 120 (54.8) | 157 (50.8) | 71 (40.8) | .14 |
| Age, years, n (%) | .061 | |||||
| <65 | 88 (40.0) | 69 (30.9) | 65 (29.7) | 97 (31.4) | 49 (28.2) | |
| 65–79 | 116 (52.7) | 140 (62.8) | 131 (59.8) | 174 (56.3) | 105 (60.3) | |
| ≥80 | 16 (7.3) | 14 (6.3) | 23 (10.5) | 38 (12.3) | 20 (11.5) | |
| Race,bn (%) | <.001 | |||||
| Asian | 38 (17.3) | 14 (6.3) | 15 (6.8) | 8 (2.6) | 1 (0.6) | |
| Black or African American | 6 (2.7) | 12 (5.4) | 4 (1.8) | 14 (4.5) | 3 (1.7) | |
| Other | 0 (0.0) | 1 (0.4) | 3 (1.4) | 0 (0.0) | 0 (0.0) | |
| White | 176 (80.0) | 196 (87.9) | 197 (90.0) | 287 (92.9) | 170 (97.7) | |
| Body weight, kg | 99.2 (90.4, 112.7) | 101.3 (89.5, 115.5) | 100.5 (87.4, 116.0) | 106.2 (96.0, 125.1) | 110.4 (97.2, 122.9) | <.001 |
| BMI, kg/m2 | 37.2 (34.1, 41.3) | 37.3 (34.3, 40.6) | 36.9 (33.6, 41.3) | 39.3 (35.4, 43.7) | 39.2 (35.3, 44.9) | <.001 |
| Waist circumference, cm | 117.0 (108.3, 126.0) | 118.4 (111.0, 127.1) | 118.0 (108.5, 126.0) | 122.0 (114.0, 132.0) | 124.8 (114.7, 134.6) | <.001 |
| Systolic BP, mmHg | 133.0 (123.0, 145.0) | 137.0 (127.0, 146.0) | 134.0 (122.0, 141.0) | 133.0 (124.0, 144.0) | 130.0 (120.0, 144.0) | .010 |
| NYHA class, n (%) | <.001 | |||||
| II | 171 (77.7) | 170 (76.2) | 149 (68.0) | 197 (63.8) | 98 (56.3) | |
| III | 49 (22.3) | 53 (23.8) | 70 (32.0) | 110 (35.6) | 76 (43.7) | |
| IV | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (0.6) | 0 (0.0) | |
| LVEF, % | 60.0 (55.0, 61.0) | 57.0 (50.0, 60.0) | 55.0 (50.0, 60.0) | 56.0 (51.0, 60.0) | 55.0 (50.0, 61.0) | <.001 |
| KCCQ-CSS, score | 65.1 (50.5, 77.1) | 65.4 (49.5, 77.1) | 57.3 (44.3, 69.8) | 55.7 (39.6, 68.2) | 50.0 (35.4, 66.7) | <.001 |
| 6MWD, metres | 336.3 (249.3, 399.8) | 338.8 (261.5, 382.0) | 288.9 (220.0, 362.0) | 265.0 (202.0, 340.0) | 260.6 (192.0, 340.0) | <.001 |
| CRP, mg/L | 3.4 (1.6, 8.0) | 2.7 (1.6, 5.9) | 3.2 (1.7, 6.5) | 4.7 (2.2, 9.7) | 4.2 (2.1, 9.5) | <.001 |
| NT-proBNP, pg/mL | 338.3 (207.2, 849.1) | 392.4 (208.9, 807.6) | 463.4 (258.8, 981.9) | 500.7 (244.8, 1091.0) | 785.7 (303.6, 1407.2) | <.001 |
| Comorbidities at screening, n (%) | ||||||
| Hypertension | 153 (69.5) | 201 (90.1) | 192 (87.7) | 262 (84.8) | 151 (86.8) | <.001 |
| Atrial fibrillation | 74 (33.6) | 89 (39.9) | 101 (46.1) | 155 (50.2) | 99 (56.9) | <.001 |
| Obstructive sleep apnoea | 17 (7.7) | 26 (11.7) | 19 (8.7) | 32 (10.4) | 25 (14.4) | .11 |
| Coronary artery disease | 98 (44.5) | 89 (39.9) | 95 (43.4) | 99 (32.0) | 72 (41.4) | .077 |
| Diabetes | 118 (53.6) | 125 (56.1) | 124 (56.6) | 158 (51.1) | 91 (52.3) | .44 |
| Concomitant medications, n (%) | ||||||
| Beta blockers | 164 (74.5) | 187 (83.9) | 182 (83.1) | 251 (81.2) | 144 (82.8) | .11 |
| SGLT2 inhibitors | 35 (15.9) | 44 (19.7) | 52 (23.7) | 52 (16.8) | 38 (21.8) | .40 |
| MRAs | 0 (0.0) | 89 (39.9) | 85 (38.8) | 119 (38.5) | 91 (52.3) | <.001 |
| Thiazide diuretics | 0 (0.0) | 102 (45.7) | 23 (10.5) | 31 (10) | 19 (10.9) | .052 |
| ACEi/ARB (ARNi) | 149 (67.7) | 194 (87.0) | 180 (82.2) | 246 (79.6) | 130 (74.7) | .32 |
| ARNi | 4 (1.8) | 13 (5.8) | 18 (8.2) | 13 (4.2) | 10 (5.7) | .22 |
| Insulin and analogues | 19 (8.6) | 20 (9.0) | 24 (11.0) | 37 (12.0) | 28 (16.1) | .013 |
| Sulfonylureas | 19 (8.6) | 26 (11.7) | 29 (13.2) | 19 (6.1) | 15 (8.6) | .35 |
| DPP-4 inhibitors | 27 (12.3) | 19 (8.5) | 16 (7.3) | 19 (6.1) | 11 (6.3) | .011 |
Percentages may not equal 100% due to rounding. Data are median (Q1, Q3) unless otherwise stated and are from the full analysis set. P-values for continuous variables computed using the Jonckheere–Terpstra trend test for continuous variables, the Cochran–Armitage trend test for binary variables, and the Cochran–Mantel–Haenszel test for multinomial variables.
6MWD, 6 min walking distance; ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNi, angiotensin receptor–neprilysin inhibitor; BMI, body mass index; CRP, high-sensitivity C-reactive protein; DM, diabetes mellitus; DPP-4, dipeptidyl peptidase-4; KCCQ-CSS, Kansas City Cardiomyopathy Questionnaire clinical summary score; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; NT-proBNP, N-terminal pro-B-type natriuretic peptide; NYHA, New York Heart Association; Q, quartile; SGLT2, sodium–glucose cotransporter 2.
aA total of 1146 participants were randomized; however, one participant was randomized in error such that the full analysis set comprises 1145 participants.
bRace was reported by the investigator.