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Vericiguat for Heart Failure in Children

This study is testing a medication called vericiguat in children (ages 29 days to 17 years) who have heart failure due to a weakened left ventricle (left ventricular systolic dysfunction). You might be able to join if you have ongoing heart failure symptoms, a specific heart structure, are already on stable heart failure medication, and your heart's pumping ability (left ventricular ejection fraction) is less than 45%. Researchers want to see if vericiguat is better than a placebo (an inactive substance) at reducing a specific blood marker (N-terminal pro-brain natriuretic peptide or NT-proBNP) after 16 weeks. The study is currently unclear on its recruitment status and plans to enroll 342 participants.

Study design
This is an interventional study, meaning participants will receive either vericiguat (as a tablet or liquid) or a placebo (inactive tablet or liquid). It plans to enroll 342 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events and discontinuations for up to approximately 8 years in an extension period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05714085

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

Recruiting
PHASE2Ages 29–17InterventionalTreatment
Merck Sharp & Dohme LLC
~342 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Vericiguat tabletVericiguat suspensionPlacebo tabletPlacebo suspension

At a glance

Recruiting sites
97 of 109 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Measured over Baseline and Week 16 of Base Period
+2 more outcomes measured

Conditions

Heart Failure
Left Ventricular Systolic Dysfunction

Explore related trials

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NCT05714085

Where you'd take part

This study runs at 109 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ankara Bilkent Şehir Hastanesi. ( Site 3300)

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Astrid Lindgrens Barnsjukhus ( Site 3001)

    Solna, Stockholm County, Swedenstudy coordinator listed

    Recruiting

  • Auckland City Hospital ( Site 2000)

    Auckland, New Zealandstudy coordinator listed

    Recruiting

  • Azienda Ospedale - Università Padova ( Site 1601)

    Padova, Veneto, Italystudy coordinator listed

    Recruiting

  • Baskent Universitesi Ankara Hastanesi ( Site 3301)

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Boston Children's Hospital ( Site 0035)

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • C.S. Mott Children's Hospital ( Site 0033)

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • Centre Hospitalier Régional de la Citadelle ( Site 0302)

    Liège, Liege, Belgiumstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

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

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.

What this trial measures

  • Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)Baseline and Week 16 of Base Period

    The change from baseline to Week 16 of the Base Period in log-transformed NT-proBNP will be reported.

  • Extension Period: Percentage of participants with one or more adverse events (AEs)Includes data collected up to a maximum of approximately 8 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Extension Period will be reported.

  • Extension Period: Percentage of participants who discontinued study drug due to an AEIncludes data collected up to a maximum of approximately 8 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Extension Period due to an AE will be reported.