Table I.
Trial | Study arms | Acuity of treatment | Patient population | Primary end point | Results |
---|---|---|---|---|---|
RELAX-AHF (n = 1161) | Seralaxin 30 μg kg−1 d−1 vs placebo for 48 h | Randomization within 16 h of hospital arrival | Patients with dyspnea at rest or minimal exertion, congestion on chest x-ray, BNP ≥350 ng/L, eGFR 30–75 mL/min per 1.73 m2, and SBP >125 mm Hg | Change in patient-reported dyspnea from baseline to day 5 (VAS AUC) Moderately or markedly improved patient-reported dyspnea at 6, 12, and 24 h (7-point Likert scale) |
Seralaxin significantly improved dyspnea compared with placebo by VAS AUC (P = .007) No difference between dyspnea improvement by Likert (P = .70) |
ASTRONAUT (n = 1639 randomized; 1615 in final efficacy analysis) | Aliskiren 150 mg daily (increased to 300 mg as tolerated) vs placebo | After a period of stabilization (median 5 d after admission) | Hemodynamically stable patients hospitalized for HF with EF ≤40%, BNP ≥400 pg/mL or NT-proBNP ≥1600 pg/mL, and signs/symptoms of fluid overload | CV death or HF rehospitalization at 6 and 12 mo | No difference in CV death or HF hospitalization at 6 (P = .41) or 12 mo (P = .36) |
PRONTO (n=104) | Clevidipine vs standard-of-care IV antihypertensives | Emergency department: door-to-treatment time of 149 mo (104, 219) | Dyspneic patients with acute HF with SBP ≥160 mm Hg | Median time and percent of patients that attain the initial prespecified SBP target range and a 15% reduction in SBP from baseline within the first 30 minutes | More patients reached the target SBP range and a 15% SBP reduction with clevidipine vs usual care (P = .0006) |
Abbreviations: eGFR, Estimated glomerular filtration rate; AUC, area under the curve; CV, cardiovascular.