for people ages up to 17 years (full criteria)
at Los Angeles, California and other locations
study started
completion around



This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.

Official Title

A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)


Heart Failure, Left Ventricular Systolic Dysfunction, Left Ventricular Dysfunction, Systolic Murmurs, Vericiguat tablet, Vericiguat suspension, Vericiguat


You can join if…

Open to people ages up to 17 years

  • Has a history of symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction
  • Has biventricular physiology with a morphologic systemic left ventricle
  • Is currently receiving stable medical therapy for HF
  • Has left ventricular ejection fraction (LVEF) <45% assessed within 3 months before randomization
  • Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed

You CAN'T join if...

  • Is clinically unstable-with at least one of the following: hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic or oral diuretic dose increase
  • Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator
  • Has a history of single ventricle heart disease or has a morphologic systemic right ventricle
  • Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device
  • Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy
  • Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations
  • Has unoperated or residual hemodynamically significant congenital cardiac malformations
  • Has hypertrophic or restrictive cardiomyopathy
  • Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis
  • Has severe pulmonary hypertension
  • Requires continuous home oxygen for significant pulmonary disease and/or has known interstitial lung disease
  • Has severe chronic kidney disease
  • Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C
  • Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications
  • Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator


  • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002) accepting new patients
    Los Angeles California 90095 United States
  • Loma Linda University Health System ( Site 0008) accepting new patients
    Loma Linda California 92354 United States


accepting new patients
Start Date
Completion Date
Merck Sharp & Dohme LLC
Plain Language Summary Merck Clinical Trials Information Sign up for this study
Phase 2/3 research study
Study Type
Expecting 342 study participants
Last Updated