Testing Vericiguat against a placebo for heart failure
Official title: 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)
Interventions
Vericiguat tablet
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Vericiguat suspension
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Placebo tablet
Placebo for vericiguat administered orally once daily in tablet form
Placebo suspension
Placebo for vericiguat administered orally once daily in suspension form
Canadian Sites (3)
Stollery Children's Hospital ( Site 0501)
Edmonton, Alberta, Canada
The Hospital for Sick Children ( Site 0500)
Toronto, Ontario, Canada
Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)
Sherbrooke, Quebec, Canada
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +Is of any sex/gender, from \>28 days to \<18 years of age inclusive. Must weigh ≥3 kg to participate.
- +Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → of the Base Period
- +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.
Exclusion
- −Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.
- −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 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
What is being given or done in this study: Vericiguat tablet, Vericiguat suspension, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → tablet, Placebo suspension.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 29 days to 17 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 342 people.
The study is currently expected to finish around April 2032.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and Week 16 of Base Period.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Base Period: Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP) — measured over Baseline and Week 16 of Base Period.
Extension Period: Percentage of participants with one or more adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Includes data collected up to a maximum of approximately 8 years.
Extension Period: Percentage of participants who discontinued study drug due to an AE — measured over Includes data collected up to a maximum of approximately 8 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05714085 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Vericiguat tabletDrug
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Vericiguat suspensionDrug
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo tabletDrug
Placebo for vericiguat administered orally once daily in tablet form
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo suspensionDrug
Placebo for vericiguat administered orally once daily in suspension form
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 29 days to 17 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 29 days to 17 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and Week 16 of Base Period.
The study as a whole is currently expected to finish around 2032-04-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 342 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Edmonton, Alberta, Canada; Toronto, Ontario, Canada; Sherbrooke, Quebec, Canada; Ann Arbor, Michigan, United States; New York, New York, United States; The Bronx, New York, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (4)
C.S. Mott Children's Hospital ( Site 0033)
Ann Arbor, Michigan, 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
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
Seattle, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.