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
NCT ID: NCT07188805
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
111 participants
INTERVENTIONAL
2025-11-28
2029-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Finerenone (Kerendia, BAY94-8862)
Participants will receive finerenone treatment.
Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 90±3 days
Placebo
Participants will receive placebo to finerenone.
Placebo
Placebo to finerenone, treatment duration will be 90±3 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.
* Elevated NT-pro BNP levels
* \>500 ng/l for children ≥ 6 months to \< 2 years of age
* \>300 ng/l, for children ≥ 2 years to \<18 years
* Heart failure etiologies including congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial/inherited and/or genetic CM; history of myocarditis (diagnosis of an acute episode was at least 3 months prior to randomization); neuromuscular disorder (eg, duchenne muscular dystrophy); inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (eg, Kawasaki disease and postoperative heart failure \[HF\]); LV noncompaction.
* Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion and being on a stable regimen for 30 days prior to randomization.
* Study participants must have a body weight ≥ 4.0 kg at Visit 1.
Exclusion Criteria
* \> 5.0 mmol/L for children ≥ 2 years of age at either screening or randomization visit
* \> 5.3 mmol/L for children ≥ 6 months to \< 2 years of age at either screening or randomization visit (if estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73m², threshold of \> 5.0 mmol/L will be used)
* Severe renal dysfunction with eGFR \< 30 ml/min/1.73m² at screening or randomization visit.
* Systolic blood pressure (SBP) \< 5th percentile for age, sex and height at screening or randomization.
* Sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to randomization.
* Treatment with a mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone) within 30 days of randomization.
* Requirement of any intravenous (IV) vasoactive agents, mechanical ventilation, mechanical circulatory support within 30 days prior to randomization.
* Recent surgical procedure or other intervention to correct or palliate CHD within 3 months prior to randomization or anticipated to undergo cardiac surgery during the 3 months after randomization.
6 Months
17 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Children's Hospital Colorado - Anschutz Medical Campus - Cardiology
Aurora, Colorado, United States
Nemours Children's Hospital -Delaware
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
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
Primary Children's Hospital
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
Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology 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 de Pediatría Juan P. Garrahan
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
Kepler Universitätsklinikum GmbH - Klinik für Kinderkardiologie
Linz, , Austria
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie
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
IESG - Instituto de Ensino da Saude e Gestao
Salvador, Estado de Bahia, Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares - EBSERH
Uberlândia, Minas Gerais, Brazil
Hospital Pequeno Principe
Curitiba, Paraná, Brazil
Fundação Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Centro de Pesquisa Clinica e Populacional Hospitalize
Porto Alegre, Rio Grande do Sul, Brazil
Campinas Clinical Research Institute (IPECC) | Campinas, Brazil
Campinas, 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
InCor HCFMUSP
São Paulo, São Paulo, Brazil
National Heart Hospital (NHH) - Dept. Pediatric Cardiology
Sofia, Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric Clinic
Plovdiv, , Bulgaria
Medical Center Nora- Heart ?OOD Child Cardiology
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
Sofia, , Bulgaria
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 v Motole - Detské kardiocentrum 2. LF UK a FN Motol
Prague, , Czechia
HUS Uusi lastensairaala - Lasten kardiologian vastaanotot
Helsinki, , Finland
Oulu University Hospital, Department of Paediatrics and Adolescent Services
Oulu, , 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, , Greece
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department
Athens, , Greece
Nosokomeio Paidon I Agia Sofia, Cardiology Department
Athens, , Greece
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart Disease
Kalithèa, , 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
Padua, , 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
Hospital Angeles (HA)-Lomas
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
Wojewodzki Szpital Specjalistyczny 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
Hospital de Santa Cruz | Pediatric Cardiology Department
Carnaxide, , Portugal
Department of Cardiology - Research Unit
Coimbra, , Portugal
Hospital Santa Marta | 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 Hospital
Yangsan, Gyeongsangnam-do, South Korea
Seoul National University Children's Hospital (SNUCH)
Jongno, Seoul, South Korea
Severance Hospital, Yonsei University Health System-Pediatrics Department
Seodaemun, , South Korea
Samsung Medical Center-Pediatrics
Seoul, , South Korea
Hospital de Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitari Vall d´Hebron_ Nefrologia
Barcelona, , Spain
Hospital Universitario Reina Sofia - Cardiologia pediatrica
Córdoba, , Spain
Hospital Universitario Ramon Y Cajal - Cardiologia pediatrica
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP)
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
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital Kaohsiung
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)
Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility
Leeds, West Yorkshire, United Kingdom
Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology
Belfast, , United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility
Bristol, , United Kingdom
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
Glasgow, , United Kingdom
University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility
Leicester, , United Kingdom
Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility
Liverpool, , United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.
Other Identifiers
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2024-519829-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
21466
Identifier Type: -
Identifier Source: org_study_id