Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Recruiting · NCT05714085 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
Placebo suspensionPlacebo tabletVericiguat suspensionVericiguat tablet
What this trial is about
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 take part
Age range
29 Days to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 14 US states.
- 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
- Centro de Atención e Investigación Clínica ( Site 1813) - Aguascalientes, Mexico
- Hacettepe Universite Hastaneleri ( Site 3304) - Ankara, Turkey (Türkiye)
- Baskent Universitesi Ankara Hastanesi ( Site 3301) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi. ( Site 3300) - Ankara, Turkey (Türkiye)
- Auckland City Hospital ( Site 2000) - Auckland, New Zealand
- Deutsches Herzzentrum Berlin ( Site 1101) - Berlin, Germany
- Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300) - Budapest, Hungary
- Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201) - Chiang Mai, Thailand
- UROLAP ( Site 1812) - Colima, Mexico
- Children's Health Ireland (CHI) at Crumlin ( Site 1400) - Dublin, Ireland
- University Medical Center Groningen ( Site 1901) - Groningen, Netherlands
- Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302) - Istanbul, Turkey (Türkiye)
- S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303) - Izmir, Turkey (Türkiye)
- Hospital Tunku Azizah-Paediatric ( Site 1700) - Kuala Lumpur, Malaysia
- Institut Jantung Negara ( Site 1705) - Kuala Lumpur, Malaysia
- Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402) - Lisbon, Portugal
- Hospital Universitario La Paz ( Site 2912) - Madrid, Spain
- Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804) - México, Mexico
- Freeman Hospital ( Site 3400) - Newcastle upon Tyne, United Kingdom
- Hôpital Universitaire Necker Enfants Malades ( Site 1001) - Paris, France
- Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004) - Paris, France
- Unidade Local de Saúde de São João ( Site 2403) - Porto, Portugal
- Seoul National University Hospital ( Site 2803) - Seoul, South Korea
- Severance Hospital, Yonsei University Health System ( Site 2800) - Seoul, South Korea
- Samsung Medical Center ( Site 2801) - Seoul, South Korea
- HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907) - Seville, Spain
- Incor - Instituto do Coracao ( Site 0400) - São Paulo, Brazil
- Universitair Medisch Centrum Utrecht ( Site 1902) - Utrecht, Netherlands
- Stollery Children's Hospital ( Site 0501) - Edmonton, Alberta, Canada
- Clinica Somer ( Site 0607) - Rionegro, Antioquia, Colombia
- CHU Bordeaux Haut-Leveque ( Site 1000) - Pessac, Aquitaine, France
- Ciensalud Ips S A S ( Site 0608) - Barranquilla, Atlántico, Colombia
- Universitaetsklinikum Freiburg ( Site 1102) - Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Universitaetsklinikum Heidelberg ( Site 1100) - Heidelberg, Baden-Wurttemberg, Germany
- Faculty of Medicine Siriraj Hospital ( Site 3200) - Bangkoknoi, Bangkok, Thailand
- Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902) - Esplugues de Llobregat, Barcelona, Spain
- Kinderklinik des Uni-Klinikums Erlangen ( Site 1104) - Erlangen, Bavaria, Germany
- Childrens University Hospital ( Site 4200) - Belgrade, Beograd, Serbia
- Institut za zdravstvenu zastitu majke i deteta Srbije ( Site 4220) - Belgrade, Beograd, Serbia
- Fundación Cardioinfantil Instituto de Cardiología ( Site 0603) - Bogotá, Bogota D.C., Colombia
Showing 60 of 109 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →