A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
Summary
The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.
Timeline
- Start
- 2021-11-02
- Primary completion
- 2024-11-20
- Completion
- 2025-02-05
Outcome
Missed primary endpoint
registry analysis (superiority test); Vericiguat vs Placebo; p = 0.219; Hazard Ratio (HR) 0.93 (95% CI 0.83 to 1.04); Log Rank NCT05093933 ↗
paper vericiguat did not reduce the risk of a composite endpoint of time to cardiovascular death or heart failure hospitalisation. PMID 40897189 ↗
release “In VICTOR, vericiguat did not meet the primary endpoint of the combined risk of heart failure hospitalization or cardiovascular death in a well-controlled patient population” bayer.com ↗
Publications
- Results Butler J, Usman MS, Anstrom KJ, Blaustein RO, Bonaca MP, Ezekowitz JA, Freitas C, Lam CSP, Lewis EF, Lindenfeld J, McMullan CJ, Mentz RJ, O'Connor C, Rosano GMC, Saldarriaga CI, Senni M, Udelson J, Voors AA, Zannad F. Soluble guanylate cyclase stimulators in patients with heart failure with reduced ejection fraction across the risk spectrum. Eur J Heart Fail. 2022 Nov;24(11):2029-2036. doi: 10.1002/ejhf.2720. Epub 2022 Nov 16.
- Results Reddy YNV, Butler J, Anstrom KJ, Blaustein RO, Bonaca MP, Corda S, Ezekowitz JA, Lam CSP, Lewis EF, Lindenfeld J, McMullan CJ, Mentz RJ, O'Connor C, Patel M, Ponikowski P, Rosano GMC, Saldarriaga CI, Senni M, Udelson J, Voors AA, Zannad F. Vericiguat Global Study in Participants with Chronic Heart Failure: Design of the VICTOR trial. Eur J Heart Fail. 2025 Feb;27(2):209-218. doi: 10.1002/ejhf.3501. Epub 2024 Oct 30.
- Results Butler J, McMullan CJ, Anstrom KJ, Barash I, Bonaca MP, Borentain M, Corda S, Ezekowitz JA, Felker GM, Gates D, Lam CSP, Lewis EF, Lindenfeld J, Mentz RJ, O'Connor CM, Ponikowski P, Reddy YNV, Rosano GMC, Saldarriaga C, Senni M, She L, Teixeira PP, Udelson J, Urbinati A, Vlajnic V, Voors AA, Xing A, Patel MJ, Zannad F; VICTOR Study Group. Vericiguat in patients with chronic heart failure and reduced ejection fraction (VICTOR): a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet. 2025 Sep 27;406(10510):1341-1350. doi: 10.1016/S0140-6736(25)01665-4. Epub 2025 Aug 30.
- Khan MS, Grayburn PA, Butler J. Cardiac reverse remodelling with vericiguat: Victory or no victory? Eur J Heart Fail. 2023 Jul;25(7):1022-1024. doi: 10.1002/ejhf.2883. Epub 2023 May 25. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vericiguat | Other / unclassified | 10 mg | Oral |