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

May 28, 2026 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

As of Protocol Amendment 2, the separate open-label extension arm of study MK-1242-043 (NCT06428383) will be incorporated into the present MK-1242-036 study as an extension period. Participants from the Base Period will be provided the opportunity to participate in the optional open-label Extension Period if eligible. After all ongoing participants are transferred into the extension period of MK-1242-036, MK-1242-043 (NCT06428383) will be formally closed.

Study Type

Interventional

Enrollment (Estimated)

342

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Liege
      • Liège, Liege, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Régional de la Citadelle ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 (0)4 321 89 77
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 9 332 24 30
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 16 34 59 98
  • Brazil
      • São Paulo, Brazil, 05403-900
        • Recruiting
        • Incor - Instituto do Coracao ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 11 2661 5450
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04012-909
        • Recruiting
        • Instituto Dante Pazzanese de Cardiology ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 11 5085 6866
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Stollery Children's Hospital ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: 780-407-1586
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5H4
        • Recruiting
        • Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: 819-346-1110, 12889
  • Colombia
    • Antioquia
      • Rionegro, Antioquia, Colombia, 054040
        • Recruiting
        • Clinica Somer ( Site 0607)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3125891661
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 08001
        • Recruiting
        • Ciensalud Ips S A S ( Site 0608)
        • Contact:
          • Study Coordinator
          • Phone Number: +573506961481
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Recruiting
        • Fundación Cardioinfantil Instituto de Cardiología ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: 6017563426 EXT 73205
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: +573133288646
      • Cali, Valle del Cauca Department, Colombia, 760042
        • Recruiting
        • Clínica Imbanaco S.A.S ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +573117441693
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Recruiting
        • Klinički bolnički centar Zagreb ( Site 3700)
        • Contact:
          • Study Coordinator
          • Phone Number: 0038512367590
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, DK-2100
        • Recruiting
        • Rigshospitalet-BørneUngeAfdelingen ( Site 0800)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 35453545
  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)
        • Contact:
          • Study Coordinator
          • Phone Number: +358503539956
  • France
      • Paris, France, 75019
        • Completed
        • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004)
      • Paris, France, 75015
        • Completed
        • Hôpital Universitaire Necker Enfants Malades ( Site 1001)
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Completed
        • CHU Bordeaux Haut-Leveque ( Site 1000)
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Completed
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002)
    • Nord
      • Lille, Nord, France, 59037
        • Completed
        • CHU Lille - Institut Coeur Poumon ( Site 1005)
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
        • Completed
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Deutsches Herzzentrum Berlin ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: + 49 30 4593 - 1000
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +4976127043230
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Completed
        • Universitaetsklinikum Heidelberg ( Site 1100)
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +4991318533750
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover ( Site 1108)
        • Contact:
          • Study Coordinator
          • Phone Number: +495115320
  • Hungary
      • Budapest, Hungary, 1096
        • Recruiting
        • Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: +3612151220
  • Ireland
      • Dublin, Ireland, D12 N512
        • Recruiting
        • Children's Health Ireland (CHI) at Crumlin ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: 01-4282854
  • Italy
    • Liguria
      • Genoa, Liguria, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: +3901056363993
    • Lombardy
      • Milan, Lombardy, Italy, 20154
        • Recruiting
        • Ospedale dei Bambini "Vittore Buzzi" ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: +390263635733
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • Recruiting
        • Ospedale Infantile Regina Margherita ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: +390113131853
    • Roma
      • Rome, Roma, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù IRCCS ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +390668592217
    • Tuscany
      • Florence, Tuscany, Italy, 50139
        • Completed
        • A.O.Universitaria Meyer ( Site 1600)
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • Azienda Ospedale - Università Padova ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: 0498213558
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Recruiting
        • Institut Jantung Negara ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: 603-26178465
      • Kuala Lumpur, Malaysia, 50300
        • Recruiting
        • Hospital Tunku Azizah-Paediatric ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: +60326003000
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Recruiting
        • Hospital Universiti Sains Malaysia ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +6097673000
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +60479492351
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, Kota Kinab
        • Recruiting
        • Hospital Queen Elizabeth II ( Site 1706)
        • Contact:
          • Study Coordinator
          • Phone Number: +6088324600
  • Mexico
      • Aguascalientes, Mexico, 20129
        • Recruiting
        • Centro de Atención e Investigación Clínica ( Site 1813)
        • Contact:
          • Study Coordinator
          • Phone Number: +525543673716
      • Colima, Mexico, 28000
        • Recruiting
        • UROLAP ( Site 1812)
        • Contact:
          • Study Coordinator
          • Phone Number: +523121552653
      • México, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +525520917905
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Recruiting
        • Morales Vargas Centro de Investigacion ( Site 1810)
        • Contact:
          • Study Coordinator
          • Phone Number: +524777160714
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44690
        • Recruiting
        • CINVEC Medica ( Site 1814)
        • Contact:
          • Study Coordinator
          • Phone Number: +523338012160
    • Mexico City
      • Mexico City, Mexico City, Mexico, 04530
        • Recruiting
        • Instituto Nacional de Pediatria ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +525556069738
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria ( Site 1816)
        • Contact:
          • Study Coordinator
          • Phone Number: +528183486173
    • State of Mexico
      • Hacienda de Las Palmas, State of Mexico, Mexico, 52763
        • Recruiting
        • INVECORDIS S.C. ( Site 1808)
        • Contact:
          • Study Coordinator
          • Phone Number: 5552469710
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Recruiting
        • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: +528331260055
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: 31503612800
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: 31 88 75 547
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 CN
        • Recruiting
        • Erasmus Medisch Centrum ( Site 1900)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031650162663
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +6493670009
  • Peru
    • Lima
      • Jesús María, Lima, Peru, 15072
        • Recruiting
        • Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)
        • Contact:
          • Study Coordinator
          • Phone Number: +51992815948
  • Poland
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-952
        • Completed
        • Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +351213594332
      • Porto, Portugal, 4200-319
        • Recruiting
        • Unidade Local de Saúde de São João ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: +351225512100
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 2790-134
        • Recruiting
        • Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +351210431000
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Recruiting
        • Childrens University Hospital ( Site 4200)
        • Contact:
          • Study Coordinator
          • Phone Number: +381641212915
      • Belgrade, Beograd, Serbia, 11000
        • Recruiting
        • Institut za zdravstvenu zastitu majke i deteta Srbije ( Site 4220)
        • Contact:
          • Study Coordinator
          • Phone Number: +381658405885
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Recruiting
        • Institute for Child and Youth Helth Care of Vojvodina ( Site 4210)
        • Contact:
          • Study Coordinator
          • Phone Number: +381642115233
  • Singapore
    • South West
      • Singapore, South West, Singapore, 119074
        • Recruiting
        • National University Hospital-Paediatrics ( Site 2600)
        • Contact:
          • Study Coordinator
          • Phone Number: 67795555
      • Singapore, South West, Singapore, 229899
        • Recruiting
        • KK Women's and Children's Hospital ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: 63941960
  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Recruiting
        • Children's Heart Disease Research Unit ( Site 2704)
        • Contact:
          • Study Coordinator
          • Phone Number: 076 844 4074.
      • Cape Town, Western Cape, South Africa, 7500
        • Active, not recruiting
        • TREAD Research ( Site 2700)
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 2803)
        • Contact:
          • Study Coordinator
          • Phone Number: 82220720266
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System ( Site 2800)
        • Contact:
          • Study Coordinator
          • Phone Number: 82222288470
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234103538
    • Kyongsangnam-do
      • Pusan, Kyongsangnam-do, South Korea, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: +82553603600
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz ( Site 2912)
        • Contact:
          • Study Coordinator
          • Phone Number: +34638372829
      • Seville, Spain, 41013
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907)
        • Contact:
          • Study Coordinator
          • Phone Number: +34669896556
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 932532100
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: 934893135
    • La Coruna
      • A Coruña, La Coruna, Spain, 15009
        • Recruiting
        • Hospital Materno-Infantil Teresa Herrera ( Site 2905)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034689979147
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28007
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915290523
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 22185
        • Recruiting
        • Skånes Universitetssjukhus Lund ( Site 3000)
        • Contact:
          • Study Coordinator
          • Phone Number: +4646171000
    • Stockholm County
      • Solna, Stockholm County, Sweden, 171 64
        • Recruiting
        • Astrid Lindgrens Barnsjukhus ( Site 3001)
        • Contact:
          • Study Coordinator
          • Phone Number: +46812373124
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: +66834739974
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 3200)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624197000
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Completed
        • Faculty of Medicine - Khon Kaen University ( Site 3202)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 3304)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 (0312) 305 25 85
      • Ankara, Turkey (Türkiye), 06490
        • Recruiting
        • Baskent Universitesi Ankara Hastanesi ( Site 3301)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 (312) 246 66 66
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi. ( Site 3300)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 552 60 00
      • Istanbul, Turkey (Türkiye), 34668
        • Recruiting
        • Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 216 542 44 44
      • Izmir, Turkey (Türkiye), 35210
        • Recruiting
        • S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 232 411 60 00
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Freeman Hospital ( Site 3400)
        • Contact:
          • Study Coordinator
          • Phone Number: 07899895040
    • London, City of
      • London, London, City of, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 7405 9200
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-825-9111
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital ( Site 0040)
        • Contact:
          • Study Coordinator
          • Phone Number: 650-721-2121
      • San Bernardino, California, United States, 92408
        • Recruiting
        • Loma Linda University Health System ( Site 0008)
        • Contact:
          • Study Coordinator
          • Phone Number: 909-558-5830
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado ( Site 0012)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-777-1234
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center ( Site 0020)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-884-2327
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital ( Site 0029)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-898-7451
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-785-0381
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital ( Site 0035)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-355-4213
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • C.S. Mott Children's Hospital ( Site 0033)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-615-0590
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-678-4357
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-305-5437
      • The Bronx, New York, United States, 10467
        • Recruiting
        • The Children's Hospital at Montefiore ( Site 0030)
        • Contact:
          • Study Coordinator
          • Phone Number: 718-741-2426
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center ( Site 0034)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-636-3016
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-444-2200
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia (CHOP) ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-590-1000
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh ( Site 0010)
        • Contact:
          • Study Coordinator
          • Phone Number: 412-692-5325
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital ( Site 0007)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-287-5760
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Children's Health-The Heart Center ( Site 0015)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-456-7000
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital ( Site 0039)
        • Contact:
          • Study Coordinator
          • Phone Number: 832-826-2806
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-987-2015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 18 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Base Period: Vericiguat
Participants in the Base Period receive 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.
Drug: Vericiguat tablet
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Other Names:
  • MK-1242
Drug: Vericiguat suspension
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Other Names:
  • MK-1242
Placebo Comparator: Base Period: Placebo
Participants in the Base Period receive placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks.
Drug: Placebo tablet
Placebo for vericiguat administered orally once daily in tablet form
Other Names:
  • Placebo for MK-1242
Drug: Placebo suspension
Placebo for vericiguat administered orally once daily in suspension form
Other Names:
  • Placebo for MK-1242
Experimental: Extension Period: Vericiguat
Participants in the Extension Period receive either 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form; following completion of the Base Period.
Drug: Vericiguat tablet
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Other Names:
  • MK-1242
Drug: Vericiguat suspension
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Other Names:
  • MK-1242

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time Frame: Baseline and Week 16 of Base Period
The change from baseline to Week 16 of the Base Period in log-transformed NT-proBNP will be reported.
Baseline and Week 16 of Base Period
Extension Period: Percentage of participants with one or more adverse events (AEs)
Time Frame: Includes data collected up to a maximum of approximately 8 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Extension Period will be reported.
Includes data collected up to a maximum of approximately 8 years
Extension Period: Percentage of participants who discontinued study drug due to an AE
Time Frame: Includes data collected up to a maximum of approximately 8 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Extension Period due to an AE will be reported.
Includes data collected up to a maximum of approximately 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP
Time Frame: Baseline and Week 52 of Base Period
The change from baseline to Week 52 of the Base Period in log-transformed NT-proBNP will be reported.
Baseline and Week 52 of Base Period
Base Period: First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization
Time Frame: Up to Week 54 of Base Period
The time from randomization to the first event of CV death, HFH, or worsening of HF without hospitalization will be reported for the Base Period.
Up to Week 54 of Base Period
Base Period: Percentage of participants with one or more adverse events (AEs)
Time Frame: Up to Week 54 of Base Period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Base Period will be reported.
Up to Week 54 of Base Period
Base Period: Percentage of participants who discontinued study drug due to an AE
Time Frame: Up to Week 52 of Base Period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Base Period due to an AE will be reported.
Up to Week 52 of Base Period
Base Period: Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
Time Frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat.
Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Base Period: Half-life (t1/2) of vericiguat in plasma
Time Frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the t1/2 of vericiguat in plasma.
Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Base Period: Oral clearance (CL/F) of plasma vericiguat
Time Frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the CL/F of vericiguat in plasma.
Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Extension Period: Change from extension period baseline to extension period Week 16 in NT-proBNP
Time Frame: Extension Period Baseline (Study Week 54) and Extension Period Week 16 (Study Week 70)
The change from the Extension Period baseline to Week 16 of the Extension Period in log-transformed NT-proBNP will be reported.
Extension Period Baseline (Study Week 54) and Extension Period Week 16 (Study Week 70)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Estimated)

April 15, 2032

Study Completion (Estimated)

April 15, 2032

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1242-036
  • MK-1242-036 (Other Identifier: MSD)
  • 2021-004399-33 (EudraCT Number)
  • MK-1242-043 (Other Identifier: MSD)
  • 2022-501238-52-00 (Registry Identifier: EU CT)
  • U1111-1275-1768 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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