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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05714085
Other study ID # 1242-036
Secondary ID MK-1242-0362021-
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 31, 2023
Est. completion date April 30, 2030

Study information

Verified date June 2024
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.


Recruitment information / eligibility

Status Recruiting
Enrollment 342
Est. completion date April 30, 2030
Est. primary completion date April 30, 2030
Accepts healthy volunteers No
Gender All
Age group 29 Days to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vericiguat tablet
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Vericiguat suspension
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Placebo tablet
Placebo for vericiguat administered orally once daily in tablet form
Placebo suspension
Placebo for vericiguat administered orally once daily in suspension form

Locations

Country Name City State
Belgium UZ Gent ( Site 0301) Gent Oost-Vlaanderen
Belgium UZ Leuven ( Site 0300) Leuven Vlaams-Brabant
Belgium Centre Hospitalier Régional de la Citadelle ( Site 0302) Liège Liege
Brazil Incor - Instituto do Coracao ( Site 0400) Sao Paulo
Brazil Instituto Dante Pazzanese de Cardiology ( Site 0402) São Paulo Sao Paulo
Canada Stollery Children's Hospital ( Site 0501) Edmonton Alberta
Canada Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502 Sherbrooke Quebec
Colombia Ciensalud Ips S A S ( Site 0608) Barranquilla Atlantico
Colombia Fundación Valle del Lili ( Site 0604) Cali Valle Del Cauca
Colombia Clinica Somer ( Site 0607) Rionegro Antioquia
Denmark Rigshospitalet-BørneUngeAfdelingen ( Site 0800) Copenhagen Hovedstaden
Finland Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900) Tampere Pirkanmaa
France CHU Lille - Institut Coeur Poumon ( Site 1005) Lille Cedex Nord
France Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003) Marseille Provence-Alpes-Cote-d Azur
France Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 10 Nantes Pays-de-la-Loire
France Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita Paris
France Hôpital Universitaire Necker Enfants Malades ( Site 1001) Paris
France CHU Bordeaux Haut-Leveque ( Site 1000) Pessac Aquitaine
Germany Kinderklinik des Uni-Klinikums Erlangen ( Site 1104) Erlangen Bayern
Germany Universitaetsklinikum Freiburg ( Site 1102) Freiburg Baden-Wurttemberg
Germany Medizinische Hochschule Hannover ( Site 1108) Hannover Niedersachsen
Germany Universitaetsklinikum Heidelberg ( Site 1100) Heidelberg Baden-Wurttemberg
Hungary Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300) Budapest
Ireland Children's Health Ireland (CHI) at Crumlin ( Site 1400) Dublin
Italy A.O.Universitaria Meyer ( Site 1600) Firenze Toscana
Korea, Republic of Pusan National University Yangsan Hospital ( Site 2802) Busan Kyongsangnam-do
Korea, Republic of Samsung Medical Center ( Site 2801) Seoul
Korea, Republic of Seoul National University Hospital ( Site 2803) Seoul
Malaysia Institut Jantung Negara ( Site 1705) Kuala Lumpur
Malaysia University Malaya Medical Centre ( Site 1701) Lembah Pantai Kuala Lumpur
Netherlands University Medical Center Groningen ( Site 1901) Groningen
Netherlands Erasmus Medisch Centrum ( Site 1900) Rotterdam Zuid-Holland
Netherlands Universitair Medisch Centrum Utrecht ( Site 1902) Utrecht
New Zealand Auckland City Hospital ( Site 2000) Auckland
Portugal Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401) Lisbon Lisboa
Portugal Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 2402) Lisbon Lisboa
Portugal Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 2403) Porto
Singapore KK Women's and Children's Hospital ( Site 2601) Singapore South West
Singapore National University Hospital-Paediatrics ( Site 2600) Singapore South West
South Africa TREAD Research ( Site 2700) Cape Town Western Cape
Spain Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902) Esplugues de Llobregat Barcelona
Spain HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904) Madrid Madrid, Comunidad De
Sweden Skånes Universitetssjukhus Lund ( Site 3000) Lund Skane Lan
Thailand Faculty of Medicine Siriraj Hospital ( Site 3200) Bangkok Krung Thep Maha Nakhon
Thailand Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201) Chiang Mai
Thailand Faculty of Medicine - Khon Kaen University ( Site 3202) Muang Khon Kaen
Turkey Ankara Bilkent Sehir Hastanesi. ( Site 3300) Ankara
Turkey Hacettepe Universite Hastaneleri ( Site 3304) Ankara
Turkey S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHISI EGITIM VE ARASTIRMA HASTANESI ( Site 3303) Izmir
United Kingdom Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401) London London, City Of
United Kingdom Freeman Hospital ( Site 3400) Newcastle upon Tyne
United States Children's Healthcare of Atlanta - Egleston Hospital ( Site 0001) Atlanta Georgia
United States Children's Hospital Colorado ( Site 0012) Aurora Colorado
United States The Children's Hospital at Montefiore ( Site 0030) 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 Loma Linda University Health System ( Site 0008) Loma Linda California
United States The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002) Los Angeles California
United States Le Bonheur Children's Hospital ( Site 0007) Memphis Tennessee
United States Columbia University Medical Center-Pediatric Cardiology ( Site 0016) New York New York
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 Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006) Saint Louis Missouri
United States Johns Hopkins All Children's Hospital ( Site 0029) Saint Petersburg Florida
United States Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019) Seattle Washington
United States Children's National Medical Center ( Site 0020) Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Colombia,  Denmark,  Finland,  France,  Germany,  Hungary,  Ireland,  Italy,  Korea, Republic of,  Malaysia,  Netherlands,  New Zealand,  Portugal,  Singapore,  South Africa,  Spain,  Sweden,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP) Change from baseline to Week 16 in log-transformed NT-proBNP Baseline and Week 16
Secondary Change from baseline to Week 52 in log-transformed NT-proBNP Change from baseline to Week 52 in log-transformed NT-proBNP 1Baseline and Week 52
Secondary First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization Time from randomization to the first event of CV death, HFH, or worsening of HF without hospitalization Up to Week 54
Secondary Participants with one or more adverse events (AE) Percentage of participants with one or more adverse events (AE) Up to Week 54
Secondary Participants who discontinued study drug due to an AE Percentage of participants who discontinued study drug due to an AE Up to Week 52
Secondary Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat 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
Secondary Half-life (t1/2) of vericiguat in plasma t1/2 of vericiguat in plasma Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
Secondary Oral clearance (CL/F) of plasma vericiguat CL/F of plasma vericiguat Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
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