Tests vericiguat in children with heart failure from weakened heart pumping
Tests vericiguat against a placebo in children with heart failure from weak heart pumping.
Plain-language title generated from the registry record
Registry title: Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Key facts
- Where
- A Coruña, Barcelona, Esplugues de Llobregat, Madrid, and Sevilla, SpainSee the 6 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for babies, children and teenagers with long-lasting heart failure caused by a weak left heart pumping chamber, who already take stable heart failure treatment.
- Age
- From more than 28 days old up to under 18 years old. Must weigh at least 3 kg (7 lb).
- Sex
- All sexes can join.
- Disease stage
- Symptomatic chronic heart failure from weak pumping of the left ventricle (the heart's main pumping chamber). Two working heart chambers, with the left ventricle supplying the body. Left ventricular ejection fraction (LVEF) below 45%, measured within 3 months before randomization.
- Earlier treatment
- Must be on stable medical therapy for heart failure now. Cannot have had a heart transplant. Cannot have received a COVID-19 vaccination within 1 week before randomization.
- Biomarker or test result
- Left ventricular ejection fraction (LVEF) below 45%.
Main reasons for not taking part
- Unstable condition, such as low blood pressure or recent IV heart medicine or IV diuretic
- Single ventricle heart disease, or the right ventricle supplying the body
- Heart transplant, waiting for a heart transplant, or an implanted ventricular assist device
- Allergy to vericiguat or other soluble guanylate cyclase (sGC) stimulators
- Use of phosphodiesterase type 5 inhibitors or an sGC stimulator
Read by machine on 11 November 2026.
Where in Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Sant Joan De Deu BarcelonaEsplugues de Llobregat, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT05714085EU 2022-501238-52-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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 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; 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 unoperated or residual hemodynamically significant congenital cardiac malformations; 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 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 hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C; 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 hypertrophic or restrictive cardiomyopathy; Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.