TABLE 4.
Change in Quality of Life Score Minimally-adjusted Model Beta-coefficient (95% CI)* |
P-value | Change in Quality of Life Score Fully-adjusted Model Beta-coefficient (95% CI)*† |
P-value | |
---|---|---|---|---|
KCCQ-OSS | ||||
Total number of physical exam signs | 4.4 (3.0, 5.7) | <0.001 | 4.0 (2.4, 5.6) | <0.001 |
Edema | 3.9 (1.8, 5.9) | <0.001 | 4.4 (1.9, 6.9) | <0.001 |
Jugular venous distention | 6.5 (2.7, 10.3) | 0.001 | 6.0 (1.7, 10.2) | 0.006 |
Rales | 4.7 (0.5, 8.9) | 0.029 | 3.0 (−2.0, 7.9) | 0.24 |
EQ5D-VAS | ||||
Total number of physical exam signs | 2.7 (1.4, 4.1) | <0.001 | 2.4 (0.7, 4.0) | 0.004 |
Edema | 3.3 (1.5, 5.2) | <0.001 | 2.8 (0.5, 5.0) | 0.015 |
Jugular venous distention | 3.9 (0.5, 7.3) | 0.026 | 3.9 (0.1, 7.8) | 0.044 |
Rales | 2.0 (−1.8, 5.7) | 0.30 | 0.5 (−3.9, 4.9) | 0.82 |
CI, confidence interval; KCCQ-OSS, Kansas City Cardiomyopathy Questionnaire Overall Summary Score; EQ5D-VAS, EQ5D visual analog scale.
Expressed per decrease in, or absence of, physical exam sign. All analyses controlled for randomization arm and baseline physical exam.
Additionally adjusted for serum creatinine, systolic blood pressure, diastolic blood pressure, diabetes mellitus, atrial fibrillation on electrocardiogram, body mass index, and heart rate.