Who is eligible for clinical trial NCT05714085?

Participants must meet the protocol's inclusion criteria for Heart Failure. The stated age range is 29 Days to 17 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05714085 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-27

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036) (NCT05714085)

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)

🟢 Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (20 items).

Location: The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002) — Los Angeles, California

Age range: 29 Days to 17 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (109 Sites)

Showing the first 25 of 109 sites.

The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002) — Los Angeles, California
Lucile Packard Children's Hospital ( Site 0040) — Palo Alto, California
Loma Linda University Health System ( Site 0008) — San Bernardino, California
Children's Hospital Colorado ( Site 0012) — Aurora, Colorado
Children's National Medical Center ( Site 0020) — Washington D.C., District of Columbia
Johns Hopkins All Children's Hospital ( Site 0029) — St. Petersburg, Florida
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001) — Atlanta, Georgia
Boston Children's Hospital ( Site 0035) — Boston, Massachusetts
C.S. Mott Children's Hospital ( Site 0033) — Ann Arbor, Michigan
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006) — St Louis, Missouri
Columbia University Medical Center-Pediatric Cardiology ( Site 0016) — New York, New York
The Children's Hospital at Montefiore ( Site 0030) — The Bronx, New York
Cincinnati Children's Hospital Medical Center ( Site 0034) — Cincinnati, Ohio
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022) — Cleveland, Ohio
Children's Hospital of Philadelphia (CHOP) ( Site 0004) — Philadelphia, Pennsylvania
Children's Hospital of Pittsburgh ( Site 0010) — Pittsburgh, Pennsylvania
Le Bonheur Children's Hospital ( Site 0007) — Memphis, Tennessee
Children's Health-The Heart Center ( Site 0015) — Dallas, Texas
Texas Children's Hospital ( Site 0039) — Houston, Texas
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019) — Seattle, Washington
Centre Hospitalier Régional de la Citadelle ( Site 0302) — Liège, Liege
UZ Gent ( Site 0301) — Ghent, Oost-Vlaanderen
UZ Leuven ( Site 0300) — Leuven, Vlaams-Brabant
Instituto Dante Pazzanese de Cardiology ( Site 0402) — São Paulo, São Paulo
Incor - Instituto do Coracao ( Site 0400) — São Paulo,

📞 Contact the Study Coordinator

Phone: (888) 577-8839

Email: Trialsites@msd.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Staged Kidney Transplantation During Combined Heart/Kidney Transplantation — Los Angeles, California
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Explore by condition: All Heart Failure clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗