Actively Recruiting
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-11
342
Participants Needed
106
Research Sites
463 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has symptomatic chronic heart failure resulting from systemic left ventricular systolic dysfunction.
- Has biventricular physiology with a morphologic systemic left ventricle.
- Is currently receiving stable medical therapy for heart failure.
- Has left ventricular ejection fraction less than 45% assessed within 3 months before randomization.
- Is any sex/gender, aged more than 28 days to less than 18 years inclusive, and weighs at least 3 kg.
- Female participants must not be pregnant or breastfeeding and must meet additional contraceptive or pregnancy test requirements.
- For Extension Period: Was randomized, received at least 1 dose of study drug, did not permanently stop study drug, and completed Week 52 visit and safety follow-up of the Base Period.
You will not qualify if you...
- Is clinically unstable, including symptomatic hypotension or recent intravenous inotrope, vasodilator, or diuretic use.
- Has allergy or sensitivity to vericiguat or related substances.
- Has single ventricle heart disease or a systemic right ventricle.
- Has had or is awaiting heart transplantation, or has an implanted ventricular assist device.
- Has uncontrolled sustained or symptomatic dysrhythmia.
- Had recent cardiovascular surgery or intervention for congenital heart defects.
- Has unoperated or residual significant congenital heart malformations.
- Has hypertrophic or restrictive cardiomyopathy.
- Has active or recent myocarditis.
- Has acute coronary syndrome, recent coronary intervention, or need for coronary revascularization.
- Has symptomatic carotid stenosis or cerebrovascular disease.
- Has severe pulmonary hypertension.
- Requires continuous home oxygen for lung disease or has interstitial lung disease.
- Has severe chronic kidney disease.
- Has serious liver disorder or Child Pugh Class C.
- Has gastrointestinal or biliary disorders affecting medication processing.
- Has significant bone disease affecting bone formation.
- Uses or will use phosphodiesterase type 5 inhibitors or sGC stimulators.
- Received COVID-19 vaccine within 1 week before randomization.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 106 locations
1
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
Los Angeles, California, United States, 90095
Actively Recruiting
2
Lucile Packard Children's Hospital ( Site 0040)
Palo Alto, California, United States, 94304
Actively Recruiting
3
Loma Linda University Health System ( Site 0008)
San Bernardino, California, United States, 92408
Actively Recruiting
4
Children's Hospital Colorado ( Site 0012)
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Children's National Medical Center ( Site 0020)
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
Johns Hopkins All Children's Hospital ( Site 0029)
St. Petersburg, Florida, United States, 33701
Actively Recruiting
7
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)
Atlanta, Georgia, United States, 30329
Actively Recruiting
8
Boston Children's Hospital ( Site 0035)
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
C.S. Mott Children's Hospital ( Site 0033)
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
New York, New York, United States, 10032
Actively Recruiting
12
The Children's Hospital at Montefiore ( Site 0030)
The Bronx, New York, United States, 10467
Actively Recruiting
13
Cincinnati Children's Hospital Medical Center ( Site 0034)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
14
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
Children's Hospital of Philadelphia (CHOP) ( Site 0004)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Children's Hospital of Pittsburgh ( Site 0010)
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
17
Le Bonheur Children's Hospital ( Site 0007)
Memphis, Tennessee, United States, 38103
Actively Recruiting
18
Children's Health-The Heart Center ( Site 0015)
Dallas, Texas, United States, 75235
Actively Recruiting
19
Texas Children's Hospital ( Site 0039)
Houston, Texas, United States, 77030
Actively Recruiting
20
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
Seattle, Washington, United States, 98105
Actively Recruiting
21
Centre Hospitalier Régional de la Citadelle ( Site 0302)
Liège, Liege, Belgium, 4000
Actively Recruiting
22
UZ Gent ( Site 0301)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
23
UZ Leuven ( Site 0300)
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
24
Instituto Dante Pazzanese de Cardiology ( Site 0402)
São Paulo, São Paulo, Brazil, 04012-909
Actively Recruiting
25
Incor - Instituto do Coracao ( Site 0400)
São Paulo, Brazil, 05403-000
Actively Recruiting
26
Stollery Children's Hospital ( Site 0501)
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
27
Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)
Sherbrooke, Quebec, Canada, J1H 5H4
Actively Recruiting
28
Clinica Somer ( Site 0607)
Rionegro, Antioquia, Colombia, 054040
Actively Recruiting
29
Ciensalud Ips S A S ( Site 0608)
Barranquilla, Atlántico, Colombia, 08001
Actively Recruiting
30
Fundación Cardioinfantil Instituto de Cardiología ( Site 0603)
Bogotá, Bogota D.C., Colombia, 110131
Actively Recruiting
31
Fundación Valle del Lili ( Site 0604)
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
32
Clínica Imbanaco S.A.S ( Site 0602)
Cali, Valle del Cauca Department, Colombia, 760042
Actively Recruiting
33
Klinički bolnički centar Zagreb ( Site 3700)
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
34
Rigshospitalet-BørneUngeAfdelingen ( Site 0800)
Copenhagen, Capital Region, Denmark, DK-2100
Actively Recruiting
35
Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)
Tampere, Pirkanmaa, Finland, 33520
Actively Recruiting
36
CHU Bordeaux Haut-Leveque ( Site 1000)
Pessac, Aquitaine, France, 33600
Completed
37
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002)
Nantes, Loire-Atlantique, France, 44093
Completed
38
CHU Lille - Institut Coeur Poumon ( Site 1005)
Lille, Nord, France, 59037
Completed
39
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
Completed
40
Hôpital Universitaire Necker Enfants Malades ( Site 1001)
Paris, France, 75015
Completed
41
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004)
Paris, France, 75019
Completed
42
Universitaetsklinikum Freiburg ( Site 1102)
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
43
Universitaetsklinikum Heidelberg ( Site 1100)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Completed
44
Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
45
Medizinische Hochschule Hannover ( Site 1108)
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
46
Deutsches Herzzentrum Berlin ( Site 1101)
Berlin, Germany, 13353
Actively Recruiting
47
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
Budapest, Hungary, 1096
Actively Recruiting
48
Children's Health Ireland (CHI) at Crumlin ( Site 1400)
Dublin, Ireland, D12 N512
Actively Recruiting
49
IRCCS Istituto Giannina Gaslini ( Site 1603)
Genoa, Liguria, Italy, 16147
Actively Recruiting
50
Ospedale dei Bambini "Vittore Buzzi" ( Site 1606)
Milan, Lombardy, Italy, 20154
Actively Recruiting
51
Ospedale Infantile Regina Margherita ( Site 1604)
Turin, Piedmont, Italy, 10126
Actively Recruiting
52
Ospedale Pediatrico Bambino Gesù IRCCS ( Site 1602)
Rome, Roma, Italy, 00165
Actively Recruiting
53
A.O.Universitaria Meyer ( Site 1600)
Florence, Tuscany, Italy, 50139
Completed
54
Azienda Ospedale - Università Padova ( Site 1601)
Padova, Veneto, Italy, 35128
Actively Recruiting
55
Hospital Universiti Sains Malaysia ( Site 1703)
Kota Bharu, Kelantan, Malaysia, 16150
Actively Recruiting
56
University Malaya Medical Centre ( Site 1701)
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
Actively Recruiting
57
Hospital Queen Elizabeth II ( Site 1706)
Kota Kinabalu, Sabah, Malaysia, Kota Kinab
Actively Recruiting
58
Hospital Tunku Azizah-Paediatric ( Site 1700)
Kuala Lumpur, Malaysia, 50300
Actively Recruiting
59
Institut Jantung Negara ( Site 1705)
Kuala Lumpur, Malaysia, 50400
Actively Recruiting
60
Morales Vargas Centro de Investigacion ( Site 1810)
León, Guanajuato, Mexico, 37000
Actively Recruiting
61
CINVEC Medica ( Site 1814)
Guadalajara, Jalisco, Mexico, 44690
Actively Recruiting
62
Instituto Nacional de Pediatria ( Site 1803)
Mexico City, Mexico City, Mexico, 04530
Actively Recruiting
63
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria ( Site 1816)
Monterrey, Nuevo León, Mexico, 66460
Actively Recruiting
64
INVECORDIS S.C. ( Site 1808)
Hacienda de Las Palmas, State of Mexico, Mexico, 52763
Actively Recruiting
65
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1800)
Ciudad Madero, Tamaulipas, Mexico, 89440
Actively Recruiting
66
Centro de Atención e Investigación Clínica ( Site 1813)
Aguascalientes, Mexico, 20129
Actively Recruiting
67
UROLAP ( Site 1812)
Colima, Mexico, 28000
Actively Recruiting
68
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804)
México, Mexico, 14080
Actively Recruiting
69
Erasmus Medisch Centrum ( Site 1900)
Rotterdam, South Holland, Netherlands, 3015 CN
Actively Recruiting
70
University Medical Center Groningen ( Site 1901)
Groningen, Netherlands, 9713 GZ
Actively Recruiting
71
Universitair Medisch Centrum Utrecht ( Site 1902)
Utrecht, Netherlands, 3584 CX
Actively Recruiting
72
Auckland City Hospital ( Site 2000)
Auckland, New Zealand, 1023
Actively Recruiting
73
Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)
Jesús María, Lima, Peru, 15072
Actively Recruiting
74
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Completed
75
Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)
Lisbon, Lisbon District, Portugal, 2790-134
Actively Recruiting
76
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)
Lisbon, Portugal, 1649-035
Actively Recruiting
77
Unidade Local de Saúde de São João ( Site 2403)
Porto, Portugal, 4200-319
Actively Recruiting
78
Childrens University Hospital ( Site 4200)
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
79
Institut za zdravstvenu zastitu majke i deteta Srbije ( Site 4220)
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
80
Institute for Child and Youth Helth Care of Vojvodina ( Site 4210)
Novi Sad, Vojvodina, Serbia, 21000
Actively Recruiting
81
National University Hospital-Paediatrics ( Site 2600)
Singapore, South West, Singapore, 119074
Actively Recruiting
82
KK Women's and Children's Hospital ( Site 2601)
Singapore, South West, Singapore, 229899
Actively Recruiting
83
TREAD Research ( Site 2700)
Cape Town, Western Cape, South Africa, 7500
Actively Recruiting
84
Children's Heart Disease Research Unit ( Site 2704)
Cape Town, Western Cape, South Africa, 7700
Actively Recruiting
85
Pusan National University Yangsan Hospital ( Site 2802)
Pusan, Kyongsangnam-do, South Korea, 50612
Actively Recruiting
86
Seoul National University Hospital ( Site 2803)
Seoul, South Korea, 03080
Actively Recruiting
87
Severance Hospital, Yonsei University Health System ( Site 2800)
Seoul, South Korea, 03722
Actively Recruiting
88
Samsung Medical Center ( Site 2801)
Seoul, South Korea, 06351
Actively Recruiting
89
Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
90
Hospital Universitari Vall d'Hebron ( Site 2903)
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
91
Hospital Materno-Infantil Teresa Herrera ( Site 2905)
A Coruña, La Coruna, Spain, 15009
Actively Recruiting
92
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)
Madrid, Madrid, Comunidad de, Spain, 28007
Actively Recruiting
93
Hospital Universitario La Paz ( Site 2912)
Madrid, Spain, 28046
Actively Recruiting
94
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907)
Seville, Spain, 41013
Actively Recruiting
95
Skånes Universitetssjukhus Lund ( Site 3000)
Lund, Skåne County, Sweden, 22185
Actively Recruiting
96
Astrid Lindgrens Barnsjukhus ( Site 3001)
Solna, Stockholm County, Sweden, 171 64
Actively Recruiting
97
Faculty of Medicine Siriraj Hospital ( Site 3200)
Bangkoknoi, Bangkok, Thailand, 10700
Actively Recruiting
98
Faculty of Medicine - Khon Kaen University ( Site 3202)
Muang, Changwat Khon Kaen, Thailand, 40002
Completed
99
Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
Chiang Mai, Thailand, 50200
Actively Recruiting
100
Hacettepe Universite Hastaneleri ( Site 3304)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
101
Baskent Universitesi Ankara Hastanesi ( Site 3301)
Ankara, Turkey (Türkiye), 06490
Actively Recruiting
102
Ankara Bilkent Şehir Hastanesi. ( Site 3300)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
103
Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302)
Istanbul, Turkey (Türkiye), 34668
Actively Recruiting
104
S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)
Izmir, Turkey (Türkiye), 35210
Actively Recruiting
105
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)
London, London, City of, United Kingdom, WC1N 3JH
Actively Recruiting
106
Freeman Hospital ( Site 3400)
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
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Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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