RecruitingPhase 2 / Phase 3

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

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
29 Days to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests vericiguat against a placebo, which has no active medicine, in children with heart failure caused by weak pumping in the heart’s left lower chamber. It checks whether vericiguat lowers NT-proBNP, a blood marker linked to heart failure, more than placebo after 16 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 28 days and younger than 18 years, and weigh at least 3 kg (about 6.6 pounds).
  • Have long-term heart failure with symptoms because the heart’s left lower chamber does not pump well.
  • Have two working lower heart chambers, with a left lower chamber that pumps blood to the body.
  • Be taking stable treatment for heart failure.
  • Have a test within 3 months before treatment assignment showing that the left lower chamber pumps out less than 45% of its blood with each beat.
  • Not be pregnant or breastfeeding. Those who can become pregnant must use highly effective birth control, have a negative pregnancy test, and have their medical, period, and recent sexual history reviewed. They must not breastfeed during treatment or for at least 30 days afterward.
  • To join the extension: have been assigned a study treatment, taken at least one dose, not stopped it permanently, and finished the Week 52 visit and safety follow-up.

Who can't join

  • Have unstable health, including low blood pressure for age or with symptoms, or recent vein-given medicines to strengthen the heartbeat, widen blood vessels, or remove extra fluid.
  • Have an allergy to vericiguat, its ingredients, or similar medicines called sGC stimulators; use or expect to use an sGC stimulator or a PDE5 inhibitor; or have had a COVID-19 vaccine within 1 week before treatment assignment.
  • Have a heart with only one lower pumping chamber or a right lower chamber that pumps to the body; have had a heart transplant; be on the highest-priority transplant waiting list (UNOS 1A or equal); or need continuous vein-given medicine to strengthen the heartbeat or an implanted heart pump.
  • Have an ongoing or symptom-causing abnormal heartbeat that treatment does not control; recent surgery or a tube-based procedure for a heart birth defect; or a heart birth defect that still greatly affects blood flow.
  • Have thick or stiff heart muscle, active or recently diagnosed heart muscle inflammation, a sudden problem with blood flow to the heart, a recent heart artery procedure, or a need for treatment to restore heart blood flow.
  • Have narrowed neck arteries or other blood vessel disease affecting the brain that causes symptoms; severe high blood pressure in the lungs; lung disease needing constant home oxygen; or disease affecting the tissue around the lungs’ air sacs.
  • Have severe long-term kidney disease, certain liver problems, or a gut or bile-system problem that could affect how the body takes in, processes, or removes medicine.
  • Have major bone disease that the study doctor thinks could change how bone forms, other than osteopenia (mildly low bone density).

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (20)

CA

CO

DC

FL

GA

MA

MI

MO

  • Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006) · St Louis, MO 63110Study Coordinator · Study contact · 800-678-4357More trials in St Louis

NY

OH

PA

TN

TX

WA