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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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)

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036) (NCT05714085) is a Phase 2 / Phase 3 interventional studying Heart Failure and Left Ventricular Systolic Dysfunction, sponsored by Merck Sharp & Dohme LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Heart Failure and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 342 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Vericiguat tablet

2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form

DRUG

Vericiguat suspension

0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form

DRUG

Placebo tablet

Placebo for vericiguat administered orally once daily in tablet form

DRUG

Placebo suspension

Placebo for vericiguat administered orally once daily in suspension form

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
Los Angeles, California, United States
Lucile Packard Children's Hospital ( Site 0040)
Palo Alto, California, United States
Loma Linda University Health System ( Site 0008)
San Bernardino, California, United States
Children's Hospital Colorado ( Site 0012)
Aurora, Colorado, United States
Children's National Medical Center ( Site 0020)
Washington D.C., District of Columbia, United States
Johns Hopkins All Children's Hospital ( Site 0029)
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)
Atlanta, Georgia, United States
Boston Children's Hospital ( Site 0035)
Boston, Massachusetts, United States
C.S. Mott Children's Hospital ( Site 0033)
Ann Arbor, Michigan, United States
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
St Louis, Missouri, United States
Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
New York, New York, United States
The Children's Hospital at Montefiore ( Site 0030)
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center ( Site 0034)
Cincinnati, Ohio, United States
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)
Cleveland, Ohio, United States
Children's Hospital of Philadelphia (CHOP) ( Site 0004)
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh ( Site 0010)
Pittsburgh, Pennsylvania, United States
Le Bonheur Children's Hospital ( Site 0007)
Memphis, Tennessee, United States
Children's Health-The Heart Center ( Site 0015)
Dallas, Texas, United States
Texas Children's Hospital ( Site 0039)
Houston, Texas, United States
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
Seattle, Washington, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05714085), the sponsor (Merck Sharp & Dohme LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05714085 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05714085?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05714085?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05714085. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05714085. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.