Heart Failure Clinical Trial

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

Summary

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. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a history of 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
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 for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed

Exclusion Criteria:

Is clinically unstable-with at least one of the following: hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic or oral diuretic dose increase
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 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 concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

342

Study ID:

NCT05714085

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 18 Locations for this study

See Locations Near You

Children's Hospital Colorado ( Site 0012)
Aurora Colorado, 80045, United States More Info
Study Coordinator
Contact
720-777-1234
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
Saint Louis Missouri, 63110, United States More Info
Study Coordinator
Contact
314-650-2205
The Children's Hospital at Montefiore ( Site 0030)
Bronx New York, 10467, United States More Info
Study Coordinator
Contact
718-741-2426
Children's Hospital of Pittsburgh ( Site 0010)
Pittsburgh Pennsylvania, 15224, United States More Info
Study Coordinator
Contact
412-692-5325
Le Bonheur Children's Hospital ( Site 0007)
Memphis Tennessee, 38103, United States More Info
Study Coordinator
Contact
832-276-9690
Rigshospitalet-BørneUngeAfdelingen ( Site 0800)
Copenhagen Hovedstaden, DK-21, Denmark More Info
Study Coordinator
Contact
+45 42406752
Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)
Tampere Pirkanmaa, 33520, Finland More Info
Study Coordinator
Contact
+358503539956
CHU Bordeaux Haut-Leveque ( Site 1000)
Pessac Aquitaine, 33600, France More Info
Study Coordinator
Contact
+33 5 57623229
CHU Lille - Institut Coeur Poumon ( Site 1005)
Lille Cedex Nord, 59037, France More Info
Study Coordinator
Contact
0320445062
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
Budapest , 1096, Hungary More Info
Study Coordinator
Contact
703820305
Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)
Lisbon Lisboa, 2790-, Portugal More Info
Study Coordinator
Contact
+351210431000
Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 2403)
Porto , 4200-, Portugal More Info
Study Coordinator
Contact
+351225512100
Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)
Esplugues de Llobregat Barcelona, 08950, Spain More Info
Study Coordinator
Contact
932532100
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)
Madrid Madrid, Comunidad De, 28007, Spain More Info
Study Coordinator
Contact
+34915290523
Skånes Universitetssjukhus Lund ( Site 3000)
Lund Skane Lan, 22185, Sweden More Info
Study Coordinator
Contact
+4646171000
Hacettepe Universite Hastaneleri ( Site 3304)
Ankara , 06230, Turkey More Info
Study Coordinator
Contact
+905422151537
Ankara City Hospital ( Site 3300)
Ankara , 06800, Turkey More Info
Study Coordinator
Contact
+905053166839
S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)
Izmir , 35210, Turkey More Info
Study Coordinator
Contact
+90 532 516 80 22

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

342

Study ID:

NCT05714085

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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