Reddy Yogesh N V, Butler Javed, Anstrom Kevin J, Blaustein Robert O, Bonaca Marc P, Corda Stefano, Ezekowitz Justin A, Lam Carolyn S P, Lewis Eldrin F, Lindenfeld JoAnn, McMullan Ciaran J, Mentz Robert J, O'Connor Christopher, Patel Mahesh, Ponikowski Piotr, Rosano Giuseppe M C, Saldarriaga Clara I, Senni Michele, Udelson James, Voors Adriaan A, Zannad Faiez
Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
Baylor Scott and White Research Institute, Dallas, TX, USA.
Eur J Heart Fail. 2025 Feb;27(2):209-218. doi: 10.1002/ejhf.3501. Epub 2024 Oct 30.
In the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial, the soluble guanylate cyclase stimulator vericiguat reduced the risk of hospitalization for heart failure (HHF) or cardiovascular death in patients with heart failure (HF) and reduced ejection fraction (HFrEF) with recent worsening HF. The effect of vericiguat in patients with HFrEF without recent worsening HF remains unknown. The VICTOR (Vericiguat Global Study in Participants with Chronic Heart Failure) trial was designed to assess the efficacy and safety of vericiguat in patients with ejection fraction ≤40% without recent worsening HF on a background of current foundational HFrEF therapy.
The primary endpoint for VICTOR is time to first event for the composite of HHF or cardiovascular death. The trial will also assess the effect of vericiguat on time to cardiovascular death, time to HHF, total HHF, and all-cause death. As an event-driven trial, at least 1080 primary events are expected, but follow-up will continue until the targeted number of at least 590 cardiovascular deaths has been reached. Approximately 6000 participants will be randomized to vericiguat or placebo.
VICTOR is the first large event-driven HFrEF trial performed in the contemporary era of quadruple foundational guideline-directed medical therapy, in a compensated ambulatory HF population. VICTOR will add important information to the evidence of the effects of vericiguat across the spectrum of patients with HFrEF.
在VICTORIA（射血分数降低的心力衰竭患者的维立西呱全球研究）试验中，可溶性鸟苷酸环化酶刺激剂维立西呱降低了近期心力衰竭加重的射血分数降低的心力衰竭（HFrEF）患者因心力衰竭住院（HHF）或心血管死亡的风险。维立西呱在近期心力衰竭未加重的HFrEF患者中的作用尚不清楚。VICTOR（慢性心力衰竭参与者的维立西呱全球研究）试验旨在评估在当前基础HFrEF治疗背景下，维立西呱对射血分数≤40%且近期心力衰竭未加重的患者的疗效和安全性。
VICTOR的主要终点是HHF或心血管死亡复合事件的首次发生时间。该试验还将评估维立西呱对心血管死亡时间、HHF时间、HHF总数和全因死亡的影响。作为一项事件驱动的试验，预计至少有1080个主要事件，但随访将持续到达到至少590例心血管死亡的目标数量。大约6000名参与者将被随机分配到维立西呱或安慰剂组。
VICTOR是在当代四重基础指南指导的药物治疗时代，在代偿性门诊心力衰竭人群中进行的首个大型事件驱动的HFrEF试验。VICTOR将为维立西呱对整个HFrEF患者群体影响的证据增添重要信息。
