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%) |