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A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
Sponsor: Bayer
Summary
Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure is a serious condition where the heart is unable to pump enough blood to meet the body's needs. This can lead to symptoms like shortness of breath, fatigue, and poor growth in children. The study treatment, finerenone (also called BAY94-8862), works by blocking a protein involved in inflammation, scarring, and thickening of the heart and blood vessels. This may help the heart to pump blood more effectively. This is the first study to explore its use specifically for children with heart failure and LVSD. The main purpose of this study is to learn if finerenone works to help the heart compared to placebo in children with heart failure and LVSD. For this, the researchers will collect and analyze data on the levels of a protein called NT-proBNP in the blood, which indicates heart stress, and monitor the safety of the treatment. The study will include children with heart failure and LVSD aged from 6 months to less than 18 years. The study participants will be randomly assigned to one of two treatment groups. Based on their group, they will receive either finerenone or a placebo for a duration of 3 months. A placebo looks like a treatment but does not have any medicine in it. Throughout the study, all participants will continue to receive their standard heart failure treatments. At the start of this study, the doctors will check each participant's medical history and current medications. If participants qualify for the treatment phase, they will undergo treatment for about 90 days. During this time, they will visit the study site at least 3 times. During these visits, the participants will: * have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured * have their heart examined by electrocardiogram (ECG) and echocardiogram * have blood samples taken * have physical examinations * answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answers 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. After the initial three-month study, eligible participants will have the option to join a nine-month open-label extension study where all will receive finerenone. Participants who choose not to enroll in the extension will have a follow-up visit 30 days after their last treatment.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Investigate the Efficacy, Safety, and PK/ PD of Finerenone, in Addition to Standard-of-care, in Pediatric Patients, 6 Months to < 18 Years of Age With Heart Failure (HF) and Left Ventricular Systolic Dysfunction (LVSD)
Key Details
Gender
All
Age Range
6 Months - 17 Years
Study Type
INTERVENTIONAL
Enrollment
111
Start Date
2025-11-19
Completion Date
2029-12-30
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 90±3 days
Placebo
Placebo to finerenone, treatment duration will be 90±3 days
Locations (133)
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 Pediatría Juan P. Garrahan
Buenos Aires, Buenos Aires, Argentina
Hospital de Niños Sor María Ludovica
La Plata, Buenos Aires, Argentina
Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina
Zárate, Buenos Aires, Argentina
Hospital General de Ninos Ricardo Gutierrez | Cardiology Department
Buenos Aires, Ciudad Auton. de 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 General de Ninos Pedro de Elizalde | Nephrology Department
Ciudad Autonoma 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
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie
Vienna, State of Vienna, Austria
Kepler Universitätsklinikum GmbH - Klinik für Kinderkardiologie
Innsbruck, Upper Austria, 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 | Cardiology
Edmonton, Alberta, Canada
BC Children's Hospital | Children's Heart Centre
Vancouver, British Columbia, Canada
Children's Hospital | Cardiology
London, Ontario, Canada
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal, Quebec, Canada
Royal University Hospital | Cardiology
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
Oulu University Hospital, Oulun yliopistollinen sairaala (OYS) - Lasten ja nuorten palvelut
Oulu, North Ostrobothnia, Finland
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
Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics
Athens, Athens, Greece
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department
Athens, Athens, Greece
Nosokomeio Paidon I Agia Sofia, Cardiology Department
Athens, Athens, Greece
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart Disease
Kallithea, Attica, 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, Bergamo, Italy
Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutiva
Bologna, Bologna, Italy
ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica
Milan, Milan, Italy
Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari
Naples, Naples, Italy
IRCCS Istituto Giannina Gaslini - Cardiologia
Genova, 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
Centro de Estudios Clínicos de Querétaro S.C.
Querétaro City, Querétaro, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City, San Luis Potosí, Mexico
Invecordis Sc.
Huixquilucan, State of Mexico, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, Mexico
Instituto Nacional de Cardiología "Ignacio Chávez"
Tlalpan, Mexico
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
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
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia Pediátrica
Coimbra, Coimbra District, Portugal
Hospital Santa Marta | Pediatric Cardiology Department
Lisbon, Lisbon District, Portugal
Hospital de Santa Cruz | Pediatric Cardiology Department
Carnaxide, Portugal
Unidade Local de Saúde de Santo António, E.P.E. - Centro Materno Infantil do Norte - Serviço de Cardiologia Pediátrica
Porto, Portugal