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A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Sponsor: Bayer
Summary
Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure with left ventricular systolic dysfunction (LVSD) is a condition where the left side of the heart is weak and struggles to pump blood effectively, leading to symptoms like shortness of breath, fatigue, and poor growth. The study treatment, finerenone (also called BAY94-8862), is under development to treat newborns, children, and young adults with heart failure and LVSD. It works by blocking a protein that contributes to inflammation, scarring, and thickening in the heart and blood vessels, which may help the heart pump more blood effectively. The main purpose of this study is to learn about how safe finerenone is and how well it works in the long-term treatment of heart failure and LVSD. To understand how safe the treatment is, the study team will gather information on the number of patients who experience medical problems after taking finerenone, also known as "treatment emergent adverse events" (TEAEs). Additionally, they will collect blood samples to measure levels of an electrolyte called potassium and monitor blood pressure. They will also assess kidneys function using the estimated glomerular filtration rate (eGFR). In this study, which is an extension of the earlier done FIORE study, finerenone will also be studied in newly enrolled newborns under 6 months with heart failure and LVSD and children and young adults from the FIORE study. The participants will be aged from newborns up to 18 years. All the participants will continue to receive their standard treatment as routine care for heart failure, along with finerenone during the study. The participants will be in the study for around 10 to 11 months, depending on whether they rolled-over from the FIORE study or are newly enrolled newborns and infants \<6 months of age. They will take study treatment for up to 9 months. During this period, at least 6 visits are planned for participants. During these visits, the study team will: * have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured * have blood samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography * answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answer * for newborns and infants, evaluate the acceptability of the study drug formulation through parents or guardians' feedback. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health a month after the participants take their last treatment.
Official title: A Phase 3, Single-arm, Open-label Extension Study to Evaluate the Safety of Finerenone in Addition to Standard of Care, in Pediatric Heart Failure Patients, From Birth to 18 Years of Age, With Left Ventricular Systolic Dysfunction (LVSD)
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
117
Start Date
2026-06-01
Completion Date
2030-12-30
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 270±7 days.
Locations (132)
Children's Hospital Colorado - Anschutz Medical Campus - Cardiology
Aurora, Colorado, United States
Nemours Children's Hospital - Delaware - Cardiology
Wilmington, Delaware, United States
UF Health Shands Hospital - Pediatric Cardiology
Gainesville, Florida, United States
Joe Dimaggio Children's Hospital - Cardiology
Hollywood, Florida, United States
Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta
Atlanta, Georgia, United States
Riley Hospital For Children - Cardiology
Indianapolis, Indiana, United States
Boston Children's Hospital - Main Campus - Cardiology
Boston, Massachusetts, United States
C.S. Mott Children's Hospital - Cardiology
Ann Arbor, Michigan, United States
Children's Mercy Hospital Kansas City - Cardiology
Kansas City, Missouri, United States
Washington University - St. Louis Children's Hospital - Cardiology
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai - Pediatric Cardiology
New York, New York, United States
Columbia University Irving Medical Center - Pediatric Cardiology
New York, New York, United States
The Children's Hospital at Montefiore - Cardiology
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Cincinnati, Ohio, United States
Cleveland Clinic Children's
Cleveland, Ohio, United States
Nationwide Children's Hospital - Cardiology
Columbus, Ohio, United States
Children's Hospital of Philadelphia - Cardiology
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh - Cardiology
Pittsburgh, Pennsylvania, United States
MUSC Shawn Jenkins Children's Hospital - Cardiology
North Charleston, South Carolina, United States
Children's Medical Center Dallas - Cardiology
Dallas, Texas, United States
Texas Children's Hospital - Cardiology
Houston, Texas, United States
Eccles Primary Children's Outpatient Services - Cardiology
Salt Lake City, Utah, United States
Hospital de Niños Sor María Ludovica
La Plata, Buenos Aires, Argentina
Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina
Zárate, Buenos Aires, Argentina
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos
Rosario, Santa Fe Province, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital de Pediatría Juan P. Garrahan
Buenos Aires, Argentina
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Buenos Aires, Argentina
Hospital General de Ninos Ricardo Gutierrez | Cardiology Department
Ciudad Autónoma de Buenos Aire, Argentina
Consultorios Médicos Dr. Doreski
Ciudad Autónoma de Buenos Aire, Argentina
Sanatorio de la Cañada
Córdoba, Argentina
Centro Cardiovascular Salta (Torzav SRL)
Salta, Argentina
Kepler Universitätsklinikum GmbH - Klinik für Kinderkardiologie
Innsbruck, Upper Austria, Austria
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie
Vienna, Vienna, Austria
UZ Leuven - Pediatric Cardiology
Leuven, Flemish Brabant, Belgium
Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology
Brussels, Belgium
UZ Antwerpen - Pediatric Cardiology
Edegem, Belgium
UZ Gent - Pediatric Cardiology
Ghent, Belgium
CHC MontLegia - Pediatric Cardiology
Liège, Belgium
Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares - EBSERH
Uberlândia, Minas Gerais, Brazil
Hospital Pequeno Principe
Curitiba, Paraná, Brazil
Centro de Pesquisa Clinica e Populacional Hospitalize
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Universidade de Caxias do Sul
Marília, São Paulo, Brazil
Liga Alvaro Bahia Contra a Mortalidade Infantil - Hospital Martagão Gesteira
Salvador, São Paulo, Brazil
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
São Paulo, São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia | Divisao de Pesquisa
São Paulo, São Paulo, Brazil
Campinas Clinical Research Institute (IPECC) | Campinas, Brazil
São Paulo, São Paulo, Brazil
Santa Casa de Misericórdia de Belo Horizonte
São Paulo, São Paulo, Brazil
InCor HCFMUSP
São Paulo, São Paulo, Brazil
University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric Clinic
Plovdiv, Plovdiv Province, Bulgaria
National Heart Hospital (NHH) - Dept. Pediatric Cardiology
Sofia, Sofia City Province, Bulgaria
Medical Center Nora- Heart ?OOD Child Cardiology
Sofia, Sofia City Province, Bulgaria
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
Sofia, Sofia City Province, Bulgaria
Stollery Children's Hospital (SCH)
Edmonton, Alberta, Canada
BC Children's Hospital | Children's Heart Centre
Vancouver, British Columbia, Canada
London Health Sciences Centre - Children's Hospital
London, Ontario, Canada
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
University of Saskatchewan, Royal University Hospital
Saskatoon, Saskatchewan, Canada
Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinika
Brno, Czechia
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Detské kardiocentrum 2. LF UK a FN Motol
Prague, Czechia
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia
Helsinki, Uusimaa, Finland
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene Herzfehler
Giessen, Hesse, Germany
Universitätsklinikum Köln - Kinderkardiologie
Cologne, Germany
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin
Tübingen, Germany
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart Disease
Kallithea, Attica, Greece
Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics
Athens, Greece
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department
Athens, Greece
Nosokomeio Paidon I Agia Sofia, Cardiology Department
Athens, Greece
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet - Gyermeksziv Kozpont
Budapest, Hungary
Rambam Health Corporation
Haifa, Israel
Edith Wolfson Medical Center (EWMC)
Holon, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Dana-Dwek Children's Hospital
Tel Aviv, Israel
Chaim Sheba Medical Center
Tel Litwinsky, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adulto
Bergamo, Italy
Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutiva
Bologna, Italy
IRCCS Istituto Giannina Gaslini - Cardiologia
Genova, Italy
ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica
Milan, Italy
Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari
Naples, Italy
Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica
Padova, Italy
Ospedale Pediatrico Bambino Gesù - Unità Terapie Cardiovascolari Avanzate
Roma, Italy
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatrica
Torino, Italy
Centro de Investigación Clínica Médica y Farmacológica S.A de C.V
Guadalajara, Jalisco, Mexico
Hospital Infantil de México "Dr. Federico Gómez"
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria
Monterrey, Nuevo León, Mexico
Invecordis Sc.
Huixquilucan, State of Mexico, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, Mexico
Centro de Estudios Clínicos de Querétaro S.C.
Querétaro, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City, Mexico
Instituto Nacional de Cardiología "Ignacio Chávez"
Tlalpan, Mexico
Pomnik Centrum Zdrowia Dziecka - Klinika Kardiologii
Warsaw, Masovian Voivodeship, Poland
Górnoslaskie Centrum Zdrowia Dziecka im. sw. Jana Pawla II SPSK Nr 6 Slaskiego UM w Katowicach - Oddzial Kardiologii Dzieciecej
Katowice, Poland
Instytut Centrum Zdrowia Matki Polki w Lodzi - Klinika Kardiologii
Lódz, Poland
Wojewódzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo-Rozwojowy Oddzial Kardiologii Dzieciecej
Wroclaw, Poland
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia Pediátrica
Coimbra, Portugal
Hospital Santa Marta | Pediatric Cardiology Department
Lisbon, Portugal
Hospital de Santa Cruz | Pediatric Cardiology Department
Lisbon, Portugal
Centro Materno infantil do Norte - Pediatric Cardiology
Porto, Portugal
ULS São João - Pediatric Department
Porto, Portugal
Pusan National University Yangsan Children's Hospital
Yangsan, Gyeongsangnam-do, South Korea
Seoul National University Hospital-Pediatrics Department
Jongno, Seoul, South Korea
Severance Hospital, Yonsei University Health System-Pediatrics Department
Seodaemun, South Korea
Samsung Medical Center-Pediatrics
Seoul, South Korea
Hospital Sant Joan De Deu Barcelona | Cardiologia pediatrica
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitari Vall D Hebron | Cardiologia pediatrica
Barcelona, Spain
Hospital Universitario Reina Sofia | Cardiologia pediatrica
Córdoba, Spain
Hospital Universitario Ramon Y Cajal | Cardiologia pediatrica
Madrid, Spain
Hospital Universitario 12 De Octubre | Cardiologia pediatrica
Madrid, Spain
Hospital Universitario La Paz | Cardiologia pediatrica
Madrid, Spain
Hospital Universitario Regional De Malaga | Cardiologia pediatrica
Málaga, Spain
Hospital Universitario Virgen Del Rocio S.L. | Cardiologia pediatrica
Seville, Spain
Skånes Universitetssjukhus Lund - Barnhjärtcentrum
Lund, Skåne County, Sweden
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Guishan, Taoyuan, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
MacKay Children's hospital
Taipei, Taiwan
Cukurova Universitesi Tip Fakultesi Hastanesi
Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Bilkent Ankara, Turkey (Türkiye)
Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji
Istanbul, Turkey (Türkiye)
Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.
Istanbul, Turkey (Türkiye)
Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast
Izmir, Turkey (Türkiye)
University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility
Leicester, Leicestershire, United Kingdom
Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility
Liverpool, Merseyside, United Kingdom
Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology
Belfast, Northern Ireland, United Kingdom
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
Glasgow, Scotland, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility
Leeds, West Yorkshire, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility
Bristol, United Kingdom