At a glance
ClinicalIndex Comparison Record- ✓History of chronic HF (NYHA Class II-IV) on standard therapy before qualifying HF decompensation
- ✓Previous HF hospitalization within 6 months prior to randomization OR IV diuretic treatment for HF without hospitalization within 3 months
- ✓Elevated natriuretic peptides: BNP ≥300 pg/mL (sinus rhythm) or ≥500 pg/mL (atrial fibrillation); NT-proBNP ≥1000 pg/mL (sinus rhythm) or ≥1600 pg/mL (atrial fibrillation) within 30 days prior to randomization
- ✓LVEF <45% assessed within 12 months prior to randomization
- ✕Clinically unstable at randomization: any IV treatment within 24 hours prior, SBP <100 mmHg, or symptomatic hypotension
- ✕Current or anticipated use of long-acting nitrates or nitric oxide donors (isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil, transdermal NTG patch, molsidomine)
- ✕Current or anticipated use of PDE5 inhibitors (vardenafil, tadalafil, sildenafil)
- ✕Current or anticipated use of sGC stimulator (riociguat) or known allergy to sGC stimulators
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT GlObal Study in Subjects With Heart Failure With Reduced EjectIon FrAction (VICTORIA)
In Brief
A Phase 3 clinical trial evaluating Vericiguat and Placebo for vericiguat for Heart Failure and Chronic Heart Failure With Reduced Ejection Fraction. Completed, enrolled 5,050 participants.
Detailed Summary
This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure with reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.
Study Details
Timeline
Interventions
2.5, 5.0, or 10.0 mg orally once daily
2.5, 5.0, or 10.0 mg orally once daily