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Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

RecruitingPhase 2/3

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)

Who can join

29 Days – 17 Years · All sexes

Full eligibility criteria
Inclusion Criteria:

* Has 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.
* Is of any sex/gender, from \>28 days to \<18 years of age inclusive. Must weigh ≥3 kg to participate.
* 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 during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.
* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period

Exclusion Criteria:

* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic.
* 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 acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.
* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease
* 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 significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation
* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.
* Has received a COVID-19 vaccination within 1 week before randomization.

About the study

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 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 342 · Started: May 31, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05714085

Locations in the U.S.

CaliforniaThe Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002), Los Angeles
Lucile Packard Children's Hospital ( Site 0040), Palo Alto
Loma Linda University Health System ( Site 0008), San Bernardino
ColoradoChildren's Hospital Colorado ( Site 0012), Aurora
District of ColumbiaChildren's National Medical Center ( Site 0020), Washington D.C.
FloridaJohns Hopkins All Children's Hospital ( Site 0029), St. Petersburg
GeorgiaChildren's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001), Atlanta
MassachusettsBoston Children's Hospital ( Site 0035), Boston
MichiganC.S. Mott Children's Hospital ( Site 0033), Ann Arbor
MissouriWashington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006), St Louis
New YorkColumbia University Medical Center-Pediatric Cardiology ( Site 0016), New York
The Children's Hospital at Montefiore ( Site 0030), The Bronx
OhioCincinnati Children's Hospital Medical Center ( Site 0034), Cincinnati
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022), Cleveland
PennsylvaniaChildren's Hospital of Philadelphia (CHOP) ( Site 0004), Philadelphia
Children's Hospital of Pittsburgh ( Site 0010), Pittsburgh
TennesseeLe Bonheur Children's Hospital ( Site 0007), Memphis
TexasChildren's Health-The Heart Center ( Site 0015), Dallas
Texas Children's Hospital ( Site 0039), Houston
WashingtonSeattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019), Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.