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Vericiguat Global Study in Participants with Chronic Heart Failure: Design of the VICTOR trial
Yogesh N V Reddy1, Javed Butler2,3, Kevin J Anstrom4
1Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
Insights
The VICTOR trial investigates vericiguat for heart failure with reduced ejection fraction (HFrEF) patients without recent worsening symptoms. This study will determine vericiguat
Area of Science:
- Cardiology
- Pharmacology
Background:
- Heart failure with reduced ejection fraction (HFrEF) affects millions globally.
- Vericiguat, a soluble guanylate cyclase stimulator, has shown promise in reducing hospitalizations for heart failure (HHF) or cardiovascular death in patients with recent worsening HFrEF.
- The efficacy and safety of vericiguat in patients with HFrEF but without recent worsening symptoms remain unestablished.
Purpose of the Study:
- To assess the efficacy and safety of vericiguat in patients with HFrEF and an ejection fraction ≤40%.
- To evaluate vericiguat's effect in a population of patients with chronic heart failure without recent worsening symptoms, on current foundational HFrEF therapy.
Main Methods:
- The VICTOR trial is a large, event-driven study involving approximately 6000 participants.
- Participants will be randomized to receive either vericiguat or a placebo.
- The primary endpoint is the composite of time to first HHF or cardiovascular death.
Main Results:
- The trial is designed to reach at least 1080 primary events and 590 cardiovascular deaths.
- Secondary endpoints include time to cardiovascular death, time to HHF, total HHF, and all-cause death.
Conclusions:
- VICTOR is the first large, event-driven HFrEF trial in the current era of quadruple foundational therapy for a compensated ambulatory HF population.
- The study will provide crucial data on vericiguat's benefits across the full spectrum of HFrEF patients.
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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