Table 1.
Characteristic | Dapagliflozin N = 121 |
Placebo N = 113 |
p-value |
---|---|---|---|
Demographics | |||
Age, y | 62.7 (10.6) | 61.4 (11.5) | 0.36 |
Male | 89 (73.6%) | 87 (77.0%) | 0.54 |
Race | 0.68 | ||
White | 71 (58.7%) | 60 (53.1%) | |
African American | 43 (35.5%) | 45 (39.8%) | |
Other | 7 (5.8%) | 8 (7.1%) | |
Medical history | |||
Duration of heart failure, y | 6.7 (5.5) | 7.5 (7.0) | 0.34 |
Previous hospitalization for heart failure | 94 (77.7%) | 93 (82.3%) | 0.38 |
Time since last hospitalization for heart failure, y | 1.4 (2.3) | 2.0 (3.3) | 0.12 |
Missing | 27 | 20 | |
Ejection fraction, % | 27 (8) | 26 (8) | 0.13 |
Ischemic heart disease | 65 (53.7%) | 58 (51.3%) | 0.71 |
Type 2 diabetes mellitus | 78 (64.5%) | 71 (62.8%) | 0.80 |
Atrial Fibrillation | 53 (43.8%) | 46 (40.7%) | 0.63 |
ICD | 80 (66.1%) | 63 (55.8%) | 0.10 |
CRT | 0.057 | ||
No | 42 (52.5%) | 43 (68.3%) | |
Yes | 38 (47.5%) | 20 (31.8%) | |
Missing | 41 | 50 | |
Baseline HF/CV medications | |||
ACEI/ARB | 64 (52.9%) | 65 (57.5%) | 0.48 |
Angiotensin receptor neprilysin inhibitor | 42 (34.7%) | 30 (26.6%) | 0.18 |
ß-blocker | 120 (99.2%) | 107 (94.7%) | 0.059 |
Hydralazine | 19 (15.7%) | 26 (23.0%) | 0.16 |
Long-acting nitrates | 41 (33.9%) | 39 (34.5%) | 0.92 |
MRA | 69 (57.0%) | 74 (65.5%) | 0.18 |
Loop diuretics | 105 (86.8%) | 94 (83.2%) | 0.44 |
Digoxin | 24 (19.8%) | 20 (17.7%) | 0.68 |
Lipid-lowering agents | 100 (82.6%) | 91 (80.5%) | 0.68 |
Anticoagulant agent | 51 (42.2%) | 40 (35.4%) | 0.29 |
Glucose lowering medications among patients with type 2 diabetes mellitus | |||
Insulin | 40 (51.3%) | 36 (50.7%) | 0.94 |
GLP-1RA | 3 (3.9%) | 1 (1.4%) | 0.62 |
DPP4-inhibitor | 11 (14.1%) | 8 (11.3%) | 0.60 |
Sulfonylurea | 19 (24.4%) | 13 (18.3%) | 0.37 |
Metformin | 29 (37.2%) | 27 (38.0%) | 0.91 |
Physical exam | |||
Body mass index (median Q1, Q3) | 31.6 (27.5, 35.9) | 30.5 (27.6, 36.3) | 0.81 |
Missing | 3 | 1 | |
Heart rate3 | 72 (12) | 72 (13) | 0.80 |
Missing | 4 | 8 | |
Systolic blood pressure3 | 124 (19) | 125 (21) | 0.50 |
Missing | 0 | 1 | |
Baseline laboratory studies | |||
NT-proBNP, pg/mL (median Q1, Q3) | 1,104 (668, 2,424) | 1,136 (551, 2,026) | 0.42 |
Missing | 0 | 2 | |
BNP, pg/mL (median Q1, Q3) | 279 (158, 577) | 242 (142, 553) | 0.44 |
Missing | 0 | 2 | |
eGFR, mL/min/1.73m^2 | 67 (21) | 70 (22) | 0.21 |
Urine albumin/creatinine ratio, mg/g (median Q1, Q3) | 21 (7, 89) | 25 (7, 106) | 0.91 |
Missing | 12 | 12 | |
Hemoglobin A1c, % | 7.1 (1.8) | 7.1 (1.7) | >0.99 |
Missing | 1 | 0 | |
Hemoglobin, g/dL | 13.5 (1.9) | 13.3 (1.7) | 0.36 |
Missing | 1 | 3 | |
Functional measures | |||
NYHA Class | 0.62 | ||
Class II | 84 (69.4%) | 75 (66.37%) | |
Class III | 37 (31.6%) | 38 (34.63%) | |
KCCQ-OSS | 67 (22) | 67 (22) | 0.90 |
KCCQ-CSS | 70 (22) | 69 (22) | 0.74 |
6-minute walk distance, meters (median Q1, Q3) | 306 (235, 369) | 305 (227, 378) | 0.93 |
Missing | 1 | 0 |
Data presented as mean (standard deviation), median (interquartile range), or n (%).
ACE-I, angiotensin converting enzyme inhibitor; ARB, angiotensin receptor blocker; BNP, B-type natriuretic peptide; CRT, cardiac resynchronization therapy; CSS, Clinical Summary Score; eGFR, estimated glomerular filtration rate; ICD, implantable cardioverter-defibrillator; KCCQ, Kansas City Cardiomyopathy Questionnaire; OSS, Overall Summary Score; MRA, mineralocorticoid antagonist; NT-proBNP, N-terminal pro-B-type natriuretic peptide.