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Table 1. Summary of baseline characteristics.

Item/category Tolvaptan (N = 46) Placebo (N = 45) p value
Demographic characteristics
 Age, years 68.0 (12.3) 65.6 (15.6) 0.4030
 Male 33 (71.7%) 33 (73.3%) 1.0000
 Hypertension 23 (50.0%) 28 (62.2%) 0.2930
 Diabetes mellitus 26 (56.5%) 26 (57.8%) 1.0000
 Coronary artery disease 16 (34.8%) 20 (44.4%) 0.7116
 Pacemaker 0 (0%) 0 (0%) 1.0000
 Implanted cardiac defibrillator 0 (0%) 0 (0%) 1.0000
 Valvular heart disease 11 (23.9%) 12 (26.7%) 0.9276
 Arrhythmia 18 (39.1%) 15 (33.3%) 0.6641
 Weight at screening, kg 65.37 (14.68) 68.93 (14.59) 0.2495
 Weight at baseline, kg 64.26 (14.65) 68.03 (14.48) 0.2206
 Height, cm 162.77 (8.51) 164.46 (7.84) 0.3261
 Body mass index (kg/m2) 24.58 (4.72) 25.37 (4.52) 0.4219
 HbA1c (%) 6.68 (1.15) 6.74 (1.11) 0.8008
 Creatinine (mg/dL) 1.44 (0.55) 1.41 (0.61) 0.8425
 Serum sodium (mmol/L) 137.0 (4.8) 137.5 (3.7) 0.5618
 Serum potassium (mmol/L) 3.95 (0.81) 4.16 (0.57) 0.1720
Congestive symptoms and signs at baseline
 New York Heart Association 0.1811
  Class II 20 (43.5%) 22 (48.9%)
  Class III 22 (47.8%) 23 (51.1%)
  Class IV 4 (8.7%) 0 (0.0%)
 Jugular venous distention 0.6990
  Absent 18 (39.1%) 17 (37.8%)
  < 6 cm 10 (21.7%) 15 (33.3%)
  6-9 cm 9 (19.6%) 8 (17.8%)
  10-15 cm 6 (13.0%) 3 (6.7%)
  > 15 cm 3 (6.5%) 2 (4.4%)
 Lower limb edema 0.5098
  Absent 9 (19.6%) 15 (33.3%)
  Slight 23 (50.0%) 18 (40.0%)
  Moderate 10 (21.7%) 9 (20.0%)
  Marked 4 (8.7%) 3 (6.7%)
 Pulmonary congestion 0.1891
  Absent 7 (15.2%) 8 (17.8%)
  Slight 16 (34.8%) 24 (53.3%)
  Moderate 19 (41.3%) 12 (26.7%)
  Marked 4 (8.7%) 1 (2.2%)
 Dyspnea 0.2436
  None 5 (10.9%) 1 (2.2%)
  Seldom 27 (58.7%) 32 (71.1%)
  Frequent 13 (28.3%) 12 (26.7%)
  Continuous 1 (2.2%) 0 (0.0%)
 Pulmonary rales 0.6831
  No rales 20 (43.5%) 22 (48.9%)
  Bases 23 (50.0%) 22 (48.9%)
  Bases to 50% way up 3 (6.5%) 1 (2.2%)