Serelaxin induced similar dyspnoea relief by VAS-AUC through Day 5 in acute heart failure patients with preserved versus reduced ejection fraction (mean change 461 vs 397 mm h; P=0.87).
RCT (n=1,161)
Does serelaxin improve dyspnoea and clinical outcomes similarly in acute heart failure patients with preserved versus reduced ejection fraction?
Serelaxin is equally effective and well-tolerated for dyspnoea relief and clinical outcomes in acute heart failure patients regardless of whether they have preserved or reduced ejection fraction.
Absolute Event Rate: 461% vs 397%
p-value: p=0.87
AIMS: Serelaxin is effective in relieving dyspnoea and improving multiple outcomes in acute heart failure (AHF). Many AHF patients have preserved ejection fraction (HFpEF). Given the lack of evidence-based therapies in this population, we evaluated the effects of serelaxin according to EF in RELAX-AHF trial. METHODS AND RESULTS: RELAX-AHF randomized 1161 AHF patients to 48-h serelaxin (30 μg/kg/day) or placebo within 16 h from presentation. We compared the effects of serelaxin on efficacy endpoints, safety endpoints, and biomarkers of organ damage between preserved (≥50%) and reduced (<50%, HFrEF) EF. HFpEF was present in 26% of patients. Serelaxin induced a similar dyspnoea relief in HFpEF vs. HFrEF patients by visual analogue scale-area under the curve (VAS-AUC) through Day 5 mean change, 461 (-195, 1117) vs. 397 (10, 783) mm h, P = 0.87, but had possibly different effects on the proportion of patients with moderately or markedly dyspnoea improvement by Likert scale at 6, 12, and 24 h odds ratio for favourable response, 1.70 (0.98, 2.95) vs. 0.85 (0.62, 1.15), interaction P = 0.030. No differences were encountered in the effect of serelaxin on short- or long-term outcome between HFpEF and HFrEF patients including cardiovascular death or hospitalization for heart/renal failure through Day 60, cardiovascular death through Day 180, and all-cause death through Day 180. Similar safety and changes in biomarkers (high-sensitivity troponin T, cystatin-C, and alanine/aspartate aminotransferases) were found in both groups. CONCLUSIONS: In AHF patients with HFpEF compared with those with HFrEF, serelaxin was well tolerated and effective in relieving dyspnoea and had a similar effect on short- and long-term outcome, including survival improvement.
Filippatos et al. (Fri,) conducted a rct in Acute heart failure (AHF) (n=1,161). Serelaxin vs. Placebo was evaluated on Dyspnoea relief by visual analogue scale-area under the curve (VAS-AUC) through Day 5 (p=0.87). Serelaxin induced similar dyspnoea relief by VAS-AUC through Day 5 in acute heart failure patients with preserved versus reduced ejection fraction (mean change 461 vs 397 mm h; P=0.87).