- Question
- Does vericiguat reduce the risk of cardiovascular death or heart failure hospitalisation in patients with heart failure with reduced ejection fraction (HFrEF) who have not had a recent worsening event?
- Design
- Phase 3, double-blind, placebo-controlled trial with 1:1 randomisation of 6105 patients at 482 sites in 36 countries. Median follow-up was 18.5 months.
- Population
- Adults aged 18 years or older with HFrEF (left ventricular ejection fraction ≤40%) without a heart failure hospitalisation in the prior 6 months or outpatient intravenous diuretic use in the prior 3 months before randomisation. Median age was 68.0 years and 47.5% had no previous heart failure hospitalisation.
- Intervention
- Oral vericiguat titrated to a target dose of 10 mg.
- Control
- Matching oral placebo.
- Primary outcome
- Time to first occurrence of the composite of cardiovascular death or heart failure hospitalisation.
- Results
- The primary endpoint occurred in 549 patients (18.0%) on vericiguat and 584 (19.1%) on placebo (HR 0.93; 95% CI 0.83-1.04; P=0.22), a non-significant difference. In nominal analyses, cardiovascular death occurred in 9.6% with vericiguat versus 11.3% with placebo (HR 0.83; 95% CI 0.71-0.97).
- Safety
- Serious adverse events occurred in 23.5% of the vericiguat group and 24.6% of the placebo group. The most common adverse event was symptomatic hypotension (11.3% with vericiguat versus 9.2% with placebo).
- Conclusion
- In patients with HFrEF and no recent worsening, vericiguat did not reduce the composite of cardiovascular death or heart failure hospitalisation, although fewer cardiovascular deaths were observed in the vericiguat group.
- Why it matters
- The trial delimited the potential benefit of vericiguat in stable HFrEF patients without recent worsening, where it did not improve the primary endpoint. The lower cardiovascular mortality is a nominal finding that requires confirmation.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026