Why the study?
The effect of vericiguat in patients with HFrEF without recent worsening heart failure remains unknown.
Does vericiguat reduce the composite of hospitalization for heart failure or cardiovascular death in patients with chronic HFrEF without recent worsening HF on foundational therapy?
Does vericiguat reduce the composite of hospitalization for heart failure or cardiovascular death in patients with chronic HFrEF without recent worsening HF on foundational therapy?
The VICTOR trial is designed to evaluate the efficacy and safety of vericiguat in a compensated ambulatory HFrEF population on contemporary foundational guideline-directed medical therapy.
Should not expand vericiguat to stable HFrEF on GDMT; challenges broader use beyond recent worsening and leaves the CV-death signal unconfirmed.
AIMS: 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. METHODS: 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. CONCLUSION: 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.
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Reddy et al. (2024) studied this question.
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