Baseline characteristics of contemporary trial participants with heart failure and reduced ejection fraction: The VICTOR trial

Abstract

Aims: To describe the baseline characteristics of the participants in the VICTOR (Vericiguat Global Study in Patients with Chronic Heart Failure; NCT05093933) trial and compare them to recent trials in patients with heart failure and reduced ejection fraction (HFrEF).

Methods and results: Baseline characteristics were evaluated in 6105 patients randomized to vericiguat or placebo. The mean age of the participants was 67 ± 11 years, 23.6% were women, 64.4% were White, and 10.7% were self-identified Black. Overall, 29.1% of participants were enrolled in Latin and South America, 27.8% and 18.5% in Eastern and Western Europe, 14.0% in Asia-Pacific and 10.6% in North America. The mean left ventricular ejection fraction was 30 ± 7% and 79% had New York Heart Association class II symptoms. Mean estimated glomerular filtration rate was 70.9 ± 24.0 ml/min/1.73 m². Median N-terminal pro-B-type natriuretic peptide level was 1476 (970-2495) pg/ml and 47.5% of participants had no prior hospitalization for heart failure. Baseline therapy included 94.4% beta-blockers, 94.3% renin-angiotensin system modulation (including 56.0% on an angiotensin receptor-neprilysin inhibitor), 77.7% mineralocorticoid receptor antagonists, 59.1% sodium-glucose cotransporter 2 inhibitors, and 32.9% implantable cardioverter-defibrillators. Overall characteristics were relatively similar to other recent HFrEF trials but the VICTOR trial enrolled a higher proportion of participants receiving contemporary drug and device therapy.

Conclusion: The VICTOR trial enrolled the most optimally treated population in a phase III heart failure trial. These features will facilitate assessment of the benefit of vericiguat and elucidate the outcomes of patients on up-to-date medical therapy.

Keywords: Clinical characteristics; Heart failure; Treatment; Vericiguat.

Figure 1

History of hospitalization for heart failure.

Figure 2

Proportion of guideline‐directed drug and device therapy across contemporary heart failure with reduced ejection fraction trials. ARNI, angiotensin receptor–neprilysin inhibitor; CRT, cardiac resynchronization therapy; ICD, implantable cardioverter‐defibrillator; MRA, mineralocorticoid receptor antagonist; RASi, renin–angiotensin system inhibitor; SGLT2i, sodium–glucose cotransporter 2 inhibitor.