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
FIORE
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)
2 other identifiers
interventional
111
23 countries
133
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2025
Typical duration for phase_3
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2025
CompletedFirst Posted
Study publicly available on registry
September 23, 2025
CompletedStudy Start
First participant enrolled
November 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2029
April 17, 2026
April 1, 2026
4 years
September 8, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in NT-proBNP levels
From baseline to Day 90±3
Secondary Outcomes (8)
Number of participants with treatment-emergent adverse events (TEAEs)
From the start of study intervention to last study intervention (up to 93 days) + 3 days
Change in serum potassium levels
From baseline to Day 90±3
Change in estimated glomerular filtration rate (eGFR)
From baseline to Day 90±3
Change in systolic blood pressure (SBP)
From baseline to Day 90±3
Change in left ventricular systolic function
From baseline to Day 90±3
- +3 more secondary outcomes
Study Arms (2)
Finerenone (Kerendia, BAY94-8862)
EXPERIMENTALParticipants will receive finerenone treatment.
Placebo
PLACEBO COMPARATORParticipants will receive placebo to finerenone.
Interventions
Finerenone in different doses, treatment duration will be 90±3 days
Eligibility Criteria
You may qualify if:
- Participants must be 6 months to \<18 years old at the time when the informed consent/assent is signed.
- 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.
You may not qualify if:
- Serum potassium:
- \> 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (133)
Children's Hospital Colorado - Anschutz Medical Campus - Cardiology
Aurora, Colorado, 80045, United States
Nemours Children's Hospital - Delaware - Cardiology
Wilmington, Delaware, 19803, United States
UF Health Shands Hospital - Pediatric Cardiology
Gainesville, Florida, 32608, United States
Joe Dimaggio Children's Hospital - Cardiology
Hollywood, Florida, 33021, United States
Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta
Atlanta, Georgia, 30329, United States
Riley Hospital For Children - Cardiology
Indianapolis, Indiana, 46202, United States
Boston Children's Hospital - Main Campus - Cardiology
Boston, Massachusetts, 02215, United States
C.S. Mott Children's Hospital - Cardiology
Ann Arbor, Michigan, 48109, United States
Children's Mercy Hospital Kansas City - Cardiology
Kansas City, Missouri, 64108, United States
Washington University - St. Louis Children's Hospital - Cardiology
St Louis, Missouri, 63110, United States
Icahn School of Medicine at Mount Sinai - Pediatric Cardiology
New York, New York, 10029, United States
Columbia University Irving Medical Center - Pediatric Cardiology
New York, New York, 10032, United States
The Children's Hospital at Montefiore - Cardiology
The Bronx, New York, 10467, United States
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Cincinnati, Ohio, 45229, United States
Cleveland Clinic Children's
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital - Cardiology
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia - Cardiology
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh - Cardiology
Pittsburgh, Pennsylvania, 15224, United States
MUSC Shawn Jenkins Children's Hospital - Cardiology
North Charleston, South Carolina, 29406, United States
Children's Medical Center Dallas - Cardiology
Dallas, Texas, 75235, United States
Texas Children's Hospital - Cardiology
Houston, Texas, 77030, United States
Eccles Primary Children's Outpatient Services - Cardiology
Salt Lake City, Utah, 84113, United States
Hospital de Niños Sor María Ludovica
La Plata, Buenos Aires, 1900, Argentina
Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina
Zárate, Buenos Aires, B2800DGH, Argentina
Hospital General de Ninos Ricardo Gutierrez | Cardiology Department
Buenos Aires, Ciudad Auton. de Buenos Aires, C1425EFD, Argentina
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Hospital de Pediatría Juan P. Garrahan
Buenos Aires, C1249ABN, Argentina
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Ciudad Autonoma de Buenos Aire, C1270AAN, Argentina
Consultorios Médicos Dr. Doreski
Ciudad Autónoma de Buenos Aire, C1426ABP, Argentina
Sanatorio de la Cañada
Córdoba, X5000BSQ, Argentina
Centro Cardiovascular Salta (Torzav SRL)
Salta, A4406BPF, Argentina
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie
Vienna, State of Vienna, 1090, Austria
Kepler Universitätsklinikum GmbH - Klinik für Kinderkardiologie
Innsbruck, Upper Austria, 6020, Austria
UZ Leuven - Pediatric Cardiology
Leuven, Flemish Brabant, 3000, Belgium
Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology
Brussels, 1200, Belgium
UZ Antwerpen - Pediatric Cardiology
Edegem, 2650, Belgium
UZ Gent - Pediatric Cardiology
Ghent, 9000, Belgium
CHC MontLegia - Pediatric Cardiology
Liège, 4000, Belgium
Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares - EBSERH
Uberlândia, Minas Gerais, 38405-325, Brazil
Hospital Pequeno Principe
Curitiba, Paraná, 80250-060, Brazil
Centro de Pesquisa Clinica e Populacional Hospitalize
Porto Alegre, Rio Grande do Sul, 90810-080, Brazil
Fundação Universidade de Caxias do Sul
Marília, São Paulo, 95070-560, Brazil
Liga Alvaro Bahia Contra a Mortalidade Infantil - Hospital Martagão Gesteira
Salvador, São Paulo, 40050050, Brazil
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
São Paulo, São Paulo, 01227-200, Brazil
Instituto Dante Pazzanese de Cardiologia | Divisao de Pesquisa
São Paulo, São Paulo, 04012-180, Brazil
Campinas Clinical Research Institute (IPECC) | Campinas, Brazil
São Paulo, São Paulo, 13060-080, Brazil
Santa Casa de Misericórdia de Belo Horizonte
São Paulo, São Paulo, 30150-221, Brazil
InCor HCFMUSP
São Paulo, São Paulo, 54030-000, Brazil
University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric Clinic
Plovdiv, Plovdiv Province, 4000, Bulgaria
National Heart Hospital (NHH) - Dept. Pediatric Cardiology
Sofia, Sofia City Province, 1309, Bulgaria
Medical Center Nora- Heart ?OOD Child Cardiology
Sofia, Sofia City Province, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
Sofia, Sofia City Province, 1431, Bulgaria
Stollery Children's Hospital (SCH)
Edmonton, Alberta, T6G 2B7, Canada
BC Children's Hospital | Children's Heart Centre
Vancouver, British Columbia, V6H 3N1, Canada
Children's Hospital | Cardiology
London, Ontario, N6A 5W9, Canada
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8, Canada
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal, Quebec, H3T 1C5, Canada
University of Saskatchewan, Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinika
Brno, 613 00, Czechia
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Detské kardiocentrum 2. LF UK a FN Motol
Prague, 150 06, Czechia
Oulu University Hospital, Oulun yliopistollinen sairaala (OYS) - Lasten ja nuorten palvelut
Oulu, North Ostrobothnia, 90220, Finland
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia
Helsinki, Uusimaa, 00290, Finland
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene Herzfehler
Giessen, Hesse, 35385, Germany
Universitätsklinikum Köln - Kinderkardiologie
Cologne, 50937, Germany
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin
Tübingen, 72076, Germany
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart Disease
Kallithea, Attica, 17674, Greece
Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics
Athens, 11527, Greece
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department
Athens, 11527, Greece
Nosokomeio Paidon I Agia Sofia, Cardiology Department
Athens, 11527, Greece
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet - Gyermeksziv Kozpont
Budapest, 1096, Hungary
Rambam Health Corporation
Haifa, 3109601????, Israel
Edith Wolfson Medical Center (EWMC)
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Dana-Dwek Children's Hospital
Tel Aviv, 6423906, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adulto
Bergamo, 24127, Italy
Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutiva
Bologna, 40138, Italy
IRCCS Istituto Giannina Gaslini - Cardiologia
Genova, 16147, Italy
ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica
Milan, 20162, Italy
Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari
Naples, 80131, Italy
Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica
Padova, 35128, Italy
Ospedale Pediatrico Bambino Gesù - Unità Terapie Cardiovascolari Avanzate
Roma, 00165, Italy
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatrica
Torino, 10126, Italy
Centro de Investigación Clínica Médica y Farmacológica S.A de C.V
Guadalajara, Jalisco, C.P.44690, Mexico
Hospital Infantil de México "Dr. Federico Gómez"
Mexico City, Mexico City, 6720, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria
Monterrey, Nuevo León, C.P. 64460, Mexico
Invecordis Sc.
Huixquilucan, State of Mexico, 52763, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, C.P. 89440, Mexico
Centro de Estudios Clínicos de Querétaro S.C.
Querétaro, 76000, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City, 72300, Mexico
Instituto Nacional de Cardiología "Ignacio Chávez"
Tlalpan, C.P. 14080, Mexico
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 51-124, Poland
Pomnik Centrum Zdrowia Dziecka - Klinika Kardiologii
Warsaw, Masovian Voivodeship, 04-730, Poland
Górnoslaskie Centrum Zdrowia Dziecka im. sw. Jana Pawla II SPSK Nr 6 Slaskiego UM w Katowicach - Oddzial Kardiologii Dzieciecej
Katowice, 40-752, Poland
Instytut Centrum Zdrowia Matki Polki w Lodzi - Klinika Kardiologii
Lódz, 93-338, Poland
Hospital de Santa Cruz | Pediatric Cardiology Department
Carnaxide, 2790-134, Portugal
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia Pediátrica
Coimbra, 3004-561, Portugal
Hospital Santa Marta | Pediatric Cardiology Department
Lisbon, 1169-024, Portugal
Centro Materno infantil do Norte - Pediatric Cardiology
Porto, 4050-651, Portugal
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Pediatria
Porto, 4200-319, Portugal
Pusan National University Yangsan Children's Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
Seoul National University Hospital-Pediatrics Department
Jongno, Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System-Pediatrics Department
Seodaemun, 03722, South Korea
Samsung Medical Center-Pediatrics
Seoul, 06351, South Korea
Hospital Sant Joan De Deu Barcelona | Cardiologia pediatrica
Esplugues de Llobregat, Barcelona, 8950, Spain
Hospital Universitari Vall D Hebron | Cardiologia pediatrica
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia | Cardiologia pediatrica
Córdoba, 14004, Spain
Hospital Universitario Ramon Y Cajal | Cardiologia pediatrica
Madrid, 28034, Spain
Hospital Universitario 12 De Octubre | Cardiologia pediatrica
Madrid, 28041, Spain
Hospital Universitario La Paz | Cardiologia pediatrica
Madrid, 28046, Spain
Hospital Universitario Regional De Malaga | Cardiologia pediatrica
Málaga, 29010, Spain
Hospital Universitario Virgen Del Rocio S.L. | Cardiologia pediatrica
Seville, 41013, Spain
Skånes Universitetssjukhus Lund - Barnhjärtcentrum
Lund, Skåne County, 222 41, Sweden
Kaohsiung Veterans General Hospital
Kaohsiung City, 813414, Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, 833, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
MacKay Children's hospital
Taipei, 104217, Taiwan
Cukurova Universitesi Tip Fakultesi Hastanesi
Adana, 1330, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Bilkent Ankara, 6800, Turkey (Türkiye)
Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji
Istanbul, 34899, Turkey (Türkiye)
Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.
Istanbul, TBC, Turkey (Türkiye)
Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast
Izmir, 35210, Turkey (Türkiye)
University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility
Leicester, Leicestershire, LE1 5WW, United Kingdom
Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility
Liverpool, Merseyside, L122AP, United Kingdom
Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology
Belfast, Northern Ireland, BT12 6BE, United Kingdom
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
Glasgow, Scotland, G51 4TF, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit
Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility
Leeds, West Yorkshire, LS1 3EX, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility
Bristol, BS2 8AE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2025
First Posted
September 23, 2025
Study Start
November 19, 2025
Primary Completion (Estimated)
November 30, 2029
Study Completion (Estimated)
December 30, 2029
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.