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New hope for kids with heart failure: drug trial aims to improve heart function

NCT ID NCT05714085

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 6 times

Summary

This study tests whether the drug vericiguat can help children with heart failure caused by a weak left heart chamber. About 342 children aged 1 month to 18 years will receive either vericiguat or a placebo for 16 weeks. The main goal is to see if the drug lowers a key heart stress marker (NT-proBNP) in the blood, which would indicate better heart function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 342 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

29 days to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

heart failure left ventricular failure systolic heart failure Ventricular Dysfunction, Left

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Left ventricular systolic dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    97 sites in 28 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • A.O.Universitaria Meyer ( Site 1600)

    COMPLETED

    Florence, Tuscany, 50139, Italy

  • Ankara Bilkent Şehir Hastanesi. ( Site 3300)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004)

    COMPLETED

    Paris, 75019, France

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)

    COMPLETED

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France

  • Astrid Lindgrens Barnsjukhus ( Site 3001)

    RECRUITING

    Solna, Stockholm County, 171 64, Sweden

  • Auckland City Hospital ( Site 2000)

    RECRUITING

    Auckland, 1023, New Zealand

  • Azienda Ospedale - Università Padova ( Site 1601)

    RECRUITING

    Padova, Veneto, 35128, Italy

  • Baskent Universitesi Ankara Hastanesi ( Site 3301)

    RECRUITING

    Ankara, 06490, Turkey (Türkiye)

  • Boston Children's Hospital ( Site 0035)

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • C.S. Mott Children's Hospital ( Site 0033)

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • CHU Bordeaux Haut-Leveque ( Site 1000)

    COMPLETED

    Pessac, Aquitaine, 33600, France

  • CHU Lille - Institut Coeur Poumon ( Site 1005)

    COMPLETED

    Lille, Nord, 59037, France

  • CINVEC Medica ( Site 1814)

    RECRUITING

    Guadalajara, Jalisco, 44690, Mexico

  • Centre Hospitalier Régional de la Citadelle ( Site 0302)

    RECRUITING

    Liège, Liege, 4000, Belgium

  • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002)

    COMPLETED

    Nantes, Loire-Atlantique, 44093, France

  • Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)

    RECRUITING

    Sherbrooke, Quebec, J1H 5H4, Canada

  • Centro de Atención e Investigación Clínica ( Site 1813)

    RECRUITING

    Aguascalientes, 20129, Mexico

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1800)

    RECRUITING

    Ciudad Madero, Tamaulipas, 89440, Mexico

  • Children's Health Ireland (CHI) at Crumlin ( Site 1400)

    RECRUITING

    Dublin, D12 N512, Ireland

  • Children's Health-The Heart Center ( Site 0015)

    RECRUITING

    Dallas, Texas, 75235, United States

  • Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Heart Disease Research Unit ( Site 2704)

    RECRUITING

    Cape Town, Western Cape, 7700, South Africa

  • Children's Hospital Colorado ( Site 0012)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia (CHOP) ( Site 0004)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh ( Site 0010)

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's National Medical Center ( Site 0020)

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Childrens University Hospital ( Site 4200)

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

  • Ciensalud Ips S A S ( Site 0608)

    RECRUITING

    Barranquilla, Atlántico, 08001, Colombia

  • Cincinnati Children's Hospital Medical Center ( Site 0034)

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Somer ( Site 0607)

    RECRUITING

    Rionegro, Antioquia, 054040, Colombia

  • Clínica Imbanaco S.A.S ( Site 0602)

    RECRUITING

    Cali, Valle del Cauca Department, 760042, Colombia

  • Columbia University Medical Center-Pediatric Cardiology ( Site 0016)

    RECRUITING

    New York, New York, 10032, United States

  • Deutsches Herzzentrum Berlin ( Site 1101)

    RECRUITING

    Berlin, 13353, Germany

  • Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302)

    RECRUITING

    Istanbul, 34668, Turkey (Türkiye)

  • Erasmus Medisch Centrum ( Site 1900)

    RECRUITING

    Rotterdam, South Holland, 3015 CN, Netherlands

  • Faculty of Medicine - Khon Kaen University ( Site 3202)

    COMPLETED

    Muang, Changwat Khon Kaen, 40002, Thailand

  • Faculty of Medicine Siriraj Hospital ( Site 3200)

    RECRUITING

    Bangkoknoi, Bangkok, 10700, Thailand

  • Freeman Hospital ( Site 3400)

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Fundación Cardioinfantil Instituto de Cardiología ( Site 0603)

    RECRUITING

    Bogotá, Bogota D.C., 110131, Colombia

  • Fundación Valle del Lili ( Site 0604)

    RECRUITING

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)

    RECRUITING

    Budapest, 1096, Hungary

  • Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)

    RECRUITING

    London, London, City of, WC1N 3JH, United Kingdom

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28007, Spain

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907)

    RECRUITING

    Seville, 41013, Spain

  • Hacettepe Universite Hastaneleri ( Site 3304)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Materno-Infantil Teresa Herrera ( Site 2905)

    RECRUITING

    A Coruña, La Coruna, 15009, Spain

  • Hospital Queen Elizabeth II ( Site 1706)

    RECRUITING

    Kota Kinabalu, Sabah, Kota Kinab, Malaysia

  • Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)

    RECRUITING

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Tunku Azizah-Paediatric ( Site 1700)

    RECRUITING

    Kuala Lumpur, 50300, Malaysia

  • Hospital Universitari Vall d'Hebron ( Site 2903)

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria ( Site 1816)

    RECRUITING

    Monterrey, Nuevo León, 66460, Mexico

  • Hospital Universitario La Paz ( Site 2912)

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universiti Sains Malaysia ( Site 1703)

    RECRUITING

    Kota Bharu, Kelantan, 16150, Malaysia

  • Hôpital Universitaire Necker Enfants Malades ( Site 1001)

    COMPLETED

    Paris, 75015, France

  • INVECORDIS S.C. ( Site 1808)

    RECRUITING

    Hacienda de Las Palmas, State of Mexico, 52763, Mexico

  • IRCCS Istituto Giannina Gaslini ( Site 1603)

    RECRUITING

    Genoa, Liguria, 16147, Italy

  • Incor - Instituto do Coracao ( Site 0400)

    RECRUITING

    São Paulo, 05403-900, Brazil

  • Institut Jantung Negara ( Site 1705)

    RECRUITING

    Kuala Lumpur, 50400, Malaysia

  • Institut za zdravstvenu zastitu majke i deteta Srbije ( Site 4220)

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

  • Institute for Child and Youth Helth Care of Vojvodina ( Site 4210)

    RECRUITING

    Novi Sad, Vojvodina, 21000, Serbia

  • Instituto Dante Pazzanese de Cardiology ( Site 0402)

    RECRUITING

    São Paulo, São Paulo, 04012-909, Brazil

  • Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)

    COMPLETED

    Jesús María, Lima, 15072, Peru

  • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804)

    RECRUITING

    México, 14080, Mexico

  • Instituto Nacional de Pediatria ( Site 1803)

    RECRUITING

    Mexico City, Mexico City, 04530, Mexico

  • Instituto Nacional de Salud del Nino San Borja ( Site 2105)

    RECRUITING

    San Borja, Lima region, 15037, Peru

  • Johns Hopkins All Children's Hospital ( Site 0029)

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • KK Women's and Children's Hospital ( Site 2601)

    RECRUITING

    Singapore, South West, 229899, Singapore

  • Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

  • King Faisal Specialist Hospital and Research Center ( Site 4100)

    RECRUITING

    Riyadh, Riyadh Region, 12713, Saudi Arabia

  • Klinički bolnički centar Zagreb ( Site 3700)

    RECRUITING

    Zagreb, City of Zagreb, 10000, Croatia

  • Le Bonheur Children's Hospital ( Site 0007)

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • Loma Linda University Health System ( Site 0008)

    RECRUITING

    San Bernardino, California, 92408, United States

  • Lucile Packard Children's Hospital ( Site 0040)

    RECRUITING

    Palo Alto, California, 94304, United States

  • Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Medizinische Hochschule Hannover ( Site 1108)

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Morales Vargas Centro de Investigacion S. C. ( Site 1810)

    RECRUITING

    León, Guanajuato, 37000, Mexico

  • National University Hospital-Paediatrics ( Site 2600)

    RECRUITING

    Singapore, South West, 119074, Singapore

  • Ospedale Infantile Regina Margherita ( Site 1604)

    RECRUITING

    Turin, Piedmont, 10126, Italy

  • Ospedale Pediatrico Bambino Gesù IRCCS ( Site 1602)

    RECRUITING

    Rome, Roma, 00165, Italy

  • Ospedale dei Bambini "Vittore Buzzi" ( Site 1606)

    RECRUITING

    Milan, Lombardy, 20154, Italy

  • Pusan National University Yangsan Hospital ( Site 2802)

    RECRUITING

    Pusan, Kyongsangnam-do, 50612, South Korea

  • Rigshospitalet-BørneUngeAfdelingen ( Site 0800)

    RECRUITING

    Copenhagen, Capital Region, DK-2100, Denmark

  • S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)

    RECRUITING

    Izmir, 35210, Turkey (Türkiye)

  • Samsung Medical Center ( Site 2801)

    RECRUITING

    Seoul, 06351, South Korea

  • Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)

    RECRUITING

    Seattle, Washington, 98105, United States

  • Seoul National University Hospital ( Site 2803)

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System ( Site 2800)

    RECRUITING

    Seoul, 03722, South Korea

  • Skånes Universitetssjukhus Lund ( Site 3000)

    RECRUITING

    Lund, Skåne County, 22185, Sweden

  • Stollery Children's Hospital ( Site 0501)

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • TREAD Research ( Site 2700)

    COMPLETED

    Cape Town, Western Cape, 7500, South Africa

  • Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)

    RECRUITING

    Tampere, Pirkanmaa, 33520, Finland

  • Texas Children's Hospital ( Site 0039)

    RECRUITING

    Houston, Texas, 77030, United States

  • The Children's Hospital at Montefiore ( Site 0030)

    RECRUITING

    The Bronx, New York, 10467, United States

  • The Hospital for Sick Children ( Site 0500)

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)

    RECRUITING

    Los Angeles, California, 90095, United States

  • UROLAP ( Site 1812)

    RECRUITING

    Colima, 28000, Mexico

  • UZ Gent ( Site 0301)

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • UZ Leuven ( Site 0300)

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)

    RECRUITING

    Lisbon, Lisbon District, 2790-134, Portugal

  • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Unidade Local de Saúde de São João ( Site 2403)

    RECRUITING

    Porto, 4200-319, Portugal

  • Universitaetsklinikum Freiburg ( Site 1102)

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Heidelberg ( Site 1100)

    COMPLETED

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitair Medisch Centrum Utrecht ( Site 1902)

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • University Malaya Medical Centre ( Site 1701)

    RECRUITING

    Lembah Pantai, Kuala Lumpur, 59100, Malaysia

  • University Medical Center Groningen ( Site 1901)

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)

    COMPLETED

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)

    RECRUITING

    St Louis, Missouri, 63110, United States

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