Table 6. Recent trials evaluating in-hospital initiation of foundational therapies in HFrEF.
| Drug class | Trial name | Number of patients | Design | Primary endpoint | Results (95% CI) | Secondary or tertiary or exploratory endpoints | Results (95% CI) |
| β-blocker | IMPACT-HF53 | 363 | Pre-discharge vs. post-discharge | Persistence of medication at 60 days | 91.2% vs. 73.4%, p < 0.0001 | Composite of death, HHF, and urgent HF visit | 45.4% vs. 46.1% (-0.09-0.11) |
| ARNI | PIONEER-HF37 | 884 | ARNI vs. enalapril | Change of NT-proBNP at 4, 8 weeks | -46.7% vs. 25.3% | Composite of death, HHF, LVAD, list on heart transplantation | 9.3% vs. 16.8% |
| HR: 0.71 (0.63-0.81) | HR: 0.54 (0.37-0.79) | ||||||
| SGLT2i | EMPA-RESPONSE-AHF108 | 80 | Empagliflozin vs. placebo | 1. Change in VAS score | 1. VAS: 1264 vs. 1650 | In-hospital worsening HF, HHF and death at 60 days | 10% vs. 33% (p = 0.014) |
| 2. Diuretic response | 2. -0.35 vs. -0.12 kg | ||||||
| 3. Change in NT-proBNP | 3. -46% vs. -42% | ||||||
| 4. Length of stay | 4. 8 vs. 8 days (All p > 0.05) | ||||||
| SOLOIST-WHF9 | 596 (1,222*) | Sotagliflozin vs. placebo | Total HHF and urgent HF visit, and CV death | 52.1% vs. 76.6 %/y | Total HHF and urgent HF visit | 40.4% vs. 63.9% | |
| HR: 0.71 (0.51-0.99) | HR: 0.64 (0.49-0.83) | ||||||
| EMPULSE71 | 530 | Empagliflozin vs. placebo | Win ratio of the composite (death, HHF, time to HF event, KCCQ-TSS ≥ 5 points) at day 90 | 53.9% vs. 39.7% | KCCQ-TSS change from baseline to day 90 | 36.19 vs. 31.73 | |
| Win ratio 1.36 (1.09-1.68) p = 0.0054 | Difference = 4.45 (0.32-8.59) | ||||||
| GDMT | STRONG-HF87 | 1078 | High-intensity care vs. usual care | 180-day HF readmission and all-cause death | 15.2% vs. 23.3% | 1. All-cause death | 1. HR: 0.84 (0.56-1.26) |
| HR: 0.66 (0.50-0.86) p = 0.0021 | 2. 90-day HF readmission and all-cause death | 2. 0.73 (0.53-1.02) |
* Total patient number in the SOLOIST-WHF trial.
ARNI, angiotensin receptor neprilysin inhibitor; CI, confidence interval; CV, cardiovascular; GDMT, guideline-directed medical therapy; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; HHF, heart failure hospitalization; HR, hazard ratio; KCCQ-TSS, Kansas City Cardiomyopathy Questionnaire-Total Symptom Score; LVAD, left ventricular assisted device; NT-proBNP, N-terminal pro B type natriuretic peptide; SGLT2i, sodium-glucose co-transporter 2 inhibitor; VAS, Visual Analogue Scale.