Table. Baseline Characteristics of Patients in the EMPEROR-Preserved Trial According to Baseline Diuretic Therapy.
Furosemide-equivalent dose | P value for interaction (no diuretic vs any dose)a | P value for trend (by dose)b | |||||
---|---|---|---|---|---|---|---|
No diuretic (n = 1179) | <40 mg (n = 1725) | 40 mg (n = 1772) | >40 mg (n = 1139) | Any dose (n = 4636) | |||
Characteristics of diuretic use | |||||||
Furosemide-equivalent dose | |||||||
Median (IQR), mg | NA | 20 (20-20) | 40 (40-40) | 80 (80-125) | 40 (40-75) | NA | NA |
Loop diuretics only, No. (%) | NA | 882 (51.1) | 1519 (85.7) | 945 (83.0) | 3346 (72.2) | NA | <.001 |
Nonloop diuretics only, No. (%) | NA | 755 (43.8) | 0 | 0 | 755 (16.3) | NA | <.001 |
Both loop and nonloop diuretics, No. (%) | NA | 88 (5.1) | 253 (14.3) | 194 (17.0) | 535 (11.5) | NA | <.001 |
Hydrochlorothiazide, No. (%) | NA | 530 (30.7) | 126 (7.1) | 92 (8.1) | 748 (16.1) | NA | .003 |
Chlorthalidone, No. (%) | NA | 55 (3.2) | 11 (0.6) | 7 (0.6) | 73 (1.6) | NA | .16 |
Indapamide, No. (%) | NA | 205 (11.9) | 64 (3.6) | 22 (1.9) | 291 (6.3) | NA | .02 |
Demographic characteristics and vitals | |||||||
Age, mean (SD), y | 70.9 (9.4) | 72.4 (8.9) | 71.7 (9.6) | 72.3 (10.0) | 72.1 (9.4) | <.001 | .02 |
Female, No. (%) | 452 (38.3) | 836 (48.5) | 795 (44.9) | 511 (44.9) | 2142 (46.2) | <.001 | .04 |
Male, No. (%) | 727 (61.7) | 889 (51.5) | 977 (55.1) | 628 (55.1) | 2494 (53.8) | ||
Race, No. (%)c | |||||||
Asian | 247 (20.9) | 305 (17.7) | 172 (9.7) | 93 (8.2) | 570 (12.3) | <.001 | <.001 |
Black | 31 (2.6) | 58 (3.4) | 97 (5.5) | 67 (5.9) | 222 (4.8) | ||
White | 803 (68.1) | 1290 (74.8) | 1372 (77.4) | 916 (80.4) | 3578 (77.2) | ||
Other or mixed raced | 98 (8.3) | 71 (4.1) | 130 (7.3) | 63 (5.5) | 264 (5.7) | ||
Region, No. (%) | |||||||
Asia | 218 (18.5) | 268 (15.5) | 122 (6.9) | 71 (6.2) | 461 (9.9) | <.001 | <.001 |
Europe | 402 (34.1) | 825 (47.8) | 782 (44.1) | 554 (48.6) | 2161 (46.6) | ||
North America | 115 (9.8) | 179 (10.4) | 183 (10.3) | 211 (18.5) | 573 (12.4) | ||
Latin America | 383 (32.5) | 389 (22.6) | 562 (31.7) | 175 (15.4) | 1126 (24.3) | ||
Heart rate, mean (SD), bpm | 69.1 (11.4) | 70.0 (11.6) | 71.1 (11.9) | 71.0 (12.6) | 70.7 (12.0) | <.001 | <.001 |
Systolic blood pressure, mean (SD), mm Hg | 132.4 (14.9) | 132.6 (15.2) | 131.6 (15.8) | 130.5 (16.8) | 131.7 (15.8) | .17 | <.001 |
Diastolic blood pressure, mean (SD), mm Hg | 76.8 (10.5) | 76.2 (10.1) | 76.0 (10.5) | 73.5 (11.2) | 75.4 (10.6) | <.001 | <.001 |
Weight, mean (SD), kg | 77.0 (17.7) | 79.7 (18.5) | 83.0 (19.1) | 87.6 (21.3) | 82.9 (19.7) | <.001 | <.001 |
BMI, mean (SD)e | 27.9 (5.2) | 29.3 (5.6) | 30.4 (5.8) | 31.6 (6.3) | 30.3 (5.9) | <.001 | <.001 |
Medical history, No. (%) | |||||||
Atrial fibrillation | 461 (39.1) | 868 (50.3) | 944 (53.3) | 666 (58.5) | 2478 (53.5) | <.001 | <.001 |
Hypertension | 1017 (86.3) | 1585 (91.9) | 1621 (91.5) | 1043 (91.6) | 4249 (91.7) | <.001 | <.001 |
CAD | 474 (40.2) | 590 (34.2) | 584 (33.0) | 405 (35.6) | 1579 (34.1) | <.001 | .0121 |
CKD | 484 (41.1) | 844 (48.9) | 1009 (56.9) | 766 (67.3) | 2619 (56.5) | <.001 | <.001 |
BMI ≥30, No. (%)e | 377 (32.0) | 707 (41.0) | 877 (49.5) | 650 (57.1) | 2234 (48.2) | <.001 | <.001 |
Diabetes | 487 (41.3) | 807 (46.8) | 888 (50.1) | 684 (60.1) | 2379 (51.3) | <.001 | <.001 |
Laboratory measurements | |||||||
Estimated GFR, mL/min/1.73 m2 | 66.6 (18.7) | 62.5 (18.2) | 59.4 (20.2) | 53.5 (20.5) | 59.1 (19.9) | <.001 | <.001 |
Estimated GFR <60 mL/min/1.73 m2, No. (%) | 438 (37.2) | 792 (45.9) | 939 (53.0) | 729 (64.0) | 2460 (53.1) | <.001 | <.001 |
Creatinine, mean (SD), mg/dL | 1.09 (0.33) | 1.11 (0.33) | 1.21 (0.41) | 1.34 (0.48) | 1.21 (0.41) | <.001 | <.001 |
Hematocrit, % | 41.7 (4.7) | 41.1 (4.5) | 40.8 (4.8) | 40.1 (5.0) | 40.7 (4.8) | <.001 | <.001 |
Heart failure history | |||||||
NYHA functional classification, No. (%) | |||||||
IIf | 1061 (90.0) | 1469 (85.2) | 1430 (80.7) | 803 (70.5) | 3702 (79.9) | <.001 | <.001 |
III | 115 (9.8) | 252 (14.6) | 338 (19.1) | 326 (28.6) | 916 (19.8) | ||
IV | 1 (0.1) | 2 (0.1) | 4 (0.2) | 10 (0.9) | 16 (0.3) | ||
Principal cause of heart failure, No. (%) | |||||||
Ischemic | 506 (42.9) | 572 (33.2) | 616 (34.8) | 364 (32.0) | 1552 (33.5) | <.001 | <.001 |
Nonischemic | 672 (57.0) | 1153 (66.8) | 1156 (65.2) | 775 (68.0) | 3084 (66.5) | ||
NT-proBNP, mean (SD), pg/mL | 1098.6 (1502.9) | 1341.8 (1633.3) | 1589.6 (2312.1) | 1824.1 (2209.5) | 1554.9 (2066.0) | <.001 | <.001 |
KCCQ clinical summary score, mean (SD) | 77.7 (18.9) | 73.1 (19.9) | 68.1 (21.1) | 62.3 (22.2) | 68.6 (21.3) | <.001 | <.001 |
Left ventricular ejection fraction, mean (SD), % | 54.3 (9.1) | 55.0 (8.7) | 53.3 (8.6) | 54.8 (8.7) | 54.3 (8.7) | .98 | .22 |
Hospitalization for heart failure in past 12 mo, No. (%) | 140 (11.9) | 306 (17.7) | 485 (27.4) | 395 (34.7) | 1186 (25.6) | <.001 | <.001 |
Device therapy, No. (%) | |||||||
Implantable cardioverter defibrillatorg | 62 (5.3) | 44 (2.6) | 68 (3.8) | 52 (4.6) | 164 (3.5) | .006 | .99 |
Cardiac resynchronizationh | 4 (0.3) | 8 (0.5) | 4 (0.2) | 8 (0.7) | 20 (0.4) | .66 | .43 |
Other heart failure therapy, No. (%) | |||||||
ACEi/ARB/ARNi | 927 (78.6) | 1436 (83.2) | 1474 (83.2) | 851 (74.7) | 3761 (81.1) | .05 | .03 |
β-Blocker | 1008 (85.5) | 1454 (84.3) | 1552 (87.6) | 1004 (88.1) | 4010 (86.5) | .37 | .005 |
MRA | 354 (30.0) | 514 (29.8) | 770 (43.5) | 529 (46.4) | 1813 (39.1) | <.001 | <.001 |
ARNi | 32 (2.7) | 26 (1.5) | 43 (2.4) | 28 (2.5) | 97 (2.1) | .20 | .70 |
ACEi/ARB/ARNi, β-blocker, and MRA | 268 (22.7) | 383 (22.2) | 567 (32.0) | 350 (30.7) | 1300 (28.0) | <.001 | <.001 |
Glucose-lowering medication, No. (%)i | |||||||
Biguanide | 294 (60.4) | 440 (54.5) | 486 (54.7) | 318 (46.5) | 1244 (52.3) | .001 | <.001 |
Sulphonamide | 102 (20.9) | 171 (21.2) | 193 (21.7) | 141 (20.6) | 505 (21.2) | .89 | .94 |
DPP-4 inhibitor | 67 (13.8) | 128 (15.9) | 96 (10.8) | 90 (13.2) | 314 (13.2) | .74 | .13 |
GLP-1 receptor agonist | 8 (1.6) | 11 (1.4) | 17 (1.9) | 22 (3.2) | 50 (2.1) | .51 | .02 |
Insulin | 113 (23.2) | 186 (23.0) | 268 (30.2) | 275 (40.2) | 729 (30.6) | .001 | <.001 |
Abbreviations: ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNi, angiotensin receptor-neprilysin inhibitor; BMI, body mass index; bpm, beats per min; CAD, coronary artery disease; CKD, chronic kidney disease; DPP-4, dipeptidyl peptidase-4; GFR, glomerular filtration rate; GLP-1, glucagonlike peptide-1; KCCQ, Kansas City Cardiomyopathy Questionnaire; MRA, mineralocorticoid receptor antagonists; NA, not applicable; NT-proBNP, N-terminal pro-brain natriuretic peptide; NYHA, New York Heart Association.
P value for interaction for comparison between diuretic vs nondiuretic groups.
P value for trend for comparison of no diuretic, <40 mg, 40 mg, and >40 mg.
Race was collected via electronic case report form based on patient-reported information in order to monitor diversity in the trial and ensure the recruitment of a representative patient population.
Other or mixed race included American Indian or Alaska Native, Native Hawaiian or Pacific Islander, and self-reported mixed race, which were consolidated to 1 category due to very low prevalence in the trial population.
Calculated as weight in kilograms divided by height in meters squared.
Includes 4 patients with NYHA I, 2 in the diuretics group and 2 in the no diuretics group.
Includes all the patients with an implantable cardioverter-defibrillator regardless of the presence or absence of cardiac resynchronization therapy.
Includes all the patients who were receiving cardiac resynchronization therapy regardless of the presence or absence of a defibrillator.
Only includes patients with type 2 diabetes at baseline.