Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- Loma Linda University Health System ( Site 0008)Recruiting
- The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)Recruiting
- Children's Hospital Colorado ( Site 0012)Recruiting
- Johns Hopkins All Children's Hospital ( Site 0029)Recruiting
- Children's Healthcare of Atlanta - Egleston Hospital ( Site 0001)Recruiting
- Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)Recruiting
- The Children's Hospital at Montefiore ( Site 0030)Recruiting
- Columbia University Medical Center-Pediatric Cardiology ( Site 0016)Recruiting
- Children's Hospital of Philadelphia (CHOP) ( Site 0004)Recruiting
- Children's Hospital of Pittsburgh ( Site 0010)Recruiting
- Le Bonheur Children's Hospital ( Site 0007)Recruiting
- Clinica Somer ( Site 0607)Recruiting
- Ciensalud Ips S A S ( Site 0608)Recruiting
- Fundacion Valle del Lili- CIC ( Site 0604)Recruiting
- Rigshospitalet-BørneUngeAfdelingen ( Site 0800)Recruiting
- Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)Recruiting
- CHU Bordeaux Haut-Leveque ( Site 1000)Recruiting
- CHU Lille - Institut Coeur Poumon ( Site 1005)Recruiting
- Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 10Recruiting
- Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)Recruiting
- Hôpital Universitaire Necker Enfants Malades ( Site 1001)Recruiting
- Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo UniversitaRecruiting
- Universitaetsklinikum Heidelberg ( Site 1100)Recruiting
- Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)Recruiting
- Children's Health Ireland (CHI) at Crumlin ( Site 1400)Recruiting
- University Malaya Medical Centre ( Site 1701)Recruiting
- Institut Jantung Negara ( Site 1705)Recruiting
- University Medical Center Groningen ( Site 1901)Recruiting
- Universitair Medisch Centrum Utrecht ( Site 1902)Recruiting
- Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 2402)Recruiting
- Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)Recruiting
- Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 2403)Recruiting
- National University Hospital-Paediatrics ( Site 2600)Recruiting
- KK Women's and Children's Hospital ( Site 2601)Recruiting
- Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)Recruiting
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)Recruiting
- Skånes Universitetssjukhus Lund ( Site 3000)Recruiting
- Faculty of Medicine Siriraj Hospital ( Site 3200)Recruiting
- Hacettepe Universite Hastaneleri ( Site 3304)Recruiting
- Ankara Bilkent Şehir Hastanesi. ( Site 3300)Recruiting
- S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Vericiguat
Placebo
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form for 52 weeks; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form for 52 weeks
Placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks