Table 2.
Primary and secondary endpoints
| Natriuresis-guided therapy | SOC | P value | ||
|---|---|---|---|---|
| Dual primary endpoint | Estimated between-group difference (95% CI) or HR [95% CI] if applicable | |||
| 24 h natriuresis (mmol)a | 409 ± 178 | 345 ± 202 | 63 (18–109) | 0.0061 | 
| 180 day HF rehospitalization or all-cause mortality (% (n))b | 31 (46) | 31 (50) | 0.92 [0.62–1.38] | 0.6980 | 
| Secondary endpoints (hierarchical testing) | ||||
| 48 h natriuresis (mmol) | 653 ± 249 | 575 ± 290 | 78 (10–145) | 0.0241 | 
| 24 h diuresis (ml) | 3,900 [3,200–4,945] | 3,330 (2,510–4,500) | 534 (160–908) | 0.0053 | 
| 48 h diuresis (ml) | 6,655 (5,401–7,824) | 5,915 (4,600–7,400) | 672 (137–1,206) | 0.0140 | 
| Length of hospital stay (days) | 6 [5–9] | 7 [5–10] | 0.1436 | |
| HF rehospitalization (% (n)) | 17 (25) | 17 (26) | 0.96 [0.56–1.67] | 0.8904 | 
| Total number of HF rehospitalizations per patient | 1 [1–1] | 1 [1–1] | 0.7663 | |
| 180 day all-cause mortality (% (n)) | 19 (29) | 21 (33) | 0.89 [0.54–1.46] | 0.6369 | 
| Percentage change in NT-proBNP (%) | ||||
| At 48 h | −22 [−48–12] | −18 [−41–17] | 0.4351 | |
| At 72 h | −33 [−61–0] | −33 [−58–8] | 0.7881 | |
aThe first part of the dual primary endpoint, 24 h total natriuresis, could not be assessed in 32 patients who underwent randomization (2 patients died within 24 h after admission, and 30 patients had missing urine collections). Student’s t-test.
bThe second part of the dual primary endpoint, all-cause mortality or HF rehospitalization, could not be assessed in one patient who underwent randomization (lost to follow-up). Cox regression.
Normally distributed variables are tested with Student’s t-test, non-normally distributed values with Wilcoxon rank/sum test and categorical values with chi-square test.