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
FIORELLO
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)
2 other identifiers
interventional
117
23 countries
132
Brief 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.
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 Jun 2026
Longer than P75 for phase_3
132 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 17, 2025
CompletedFirst Posted
Study publicly available on registry
September 25, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2030
June 29, 2026
June 1, 2026
4.6 years
September 17, 2025
June 26, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Number of participants with treatment-emergent adverse events (TEAEs)
TEAEs will be mapped to Medical Dictionary for Regulatory Activities (MedDRA) terms.
From the start of study intervention to last study intervention (up to 277 days) + 3 days
Change in serum potassium levels
From baseline to Day 270±7
Change in systolic blood pressure (SBP)
From baseline to Day 270±7
Change in estimated glomerular filtration rate (eGFR)
From baseline to Day 270±7
Secondary Outcomes (5)
Change in NT-proBNP levels
From baseline to Day 270±7
Change in left ventricular systolic function
From baseline to Day 270±7
Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md)
Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to Day 270±7
Area under the curve for finerenone concentration in plasma after multiple doses (AUCτ,md)
Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to Day 270±7
Taste and Texture Questionnaire of the pediatric formulation
On Day 30±3 and Day 270±7
Study Arms (1)
Finerenone Open-Label Safety Extension
EXPERIMENTALParticipants will receive finerenone treatment.
Interventions
Finerenone in different doses, treatment duration will be 270±7 days.
Eligibility Criteria
You may qualify if:
- For participants rolling over from randomized controlled trial (RCT): Prior participation in the finerenone Phase 3 study FIORE (21466) and not permanently discontinued from the study intervention prior to the end of treatment (EoT) visit in FIORE.
- For newly enrolled infants \<6 months of age: Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.
- For newly enrolled infants \<6 months of age: Elevated NT-pro BNP levels (\> 500 mg/L) at screening.
- For newly enrolled infants \<6 months of age: Heart failure (HF) etiologies include 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 at least 3 months prior to treatment assignment); neuromuscular disorder; inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (e.g., Kawasaki disease and postoperative HF); LV noncompaction.
- For newly enrolled infants \<6 months of age: Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion (on a stable regimen for 30 days before baseline).
- Newly enrolled newborns and infants \< 6 months of age must have a body weight of ≥3 kg at Visit 1.
You may not qualify if:
- For participants rolling over from randomized controlled trial (RCT): To roll-over to FIORELLO, all participants: Potassium (K+) \>5.5 mmol/L. After unblinding:
- For participants who received finerenone in FIORE: K+ \>5.5 mmol/ L
- For participants rolling over from RCT: Severe renal dysfunction with estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m² at FIORE EoT or Visit 1.
- For newly enrolled infants \< 6 months of age: Severe renal dysfunction with eGFR \< 30 ml/min/1.73m2 at screening or Visit 1.
- Treatment with a mineralocorticoid receptor antagonist, other than the study intervention, (e.g., spironolactone, eplerenone) within 30 days of Visit 1.
- Requirement of any intravenous (IV) vasoactive agents; mechanical ventilation; mechanical circulatory support; sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (132)
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
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
Buenos Aires, C1270, Argentina
Consultorios Médicos Dr. Doreski
Buenos Aires, C1426ABP, Argentina
Hospital General de Ninos Ricardo Gutierrez | Cardiology Department
Ciudad Autónoma de Buenos Aire, C1425EFD, 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 Antwerpen - Pediatric Cardiology
Edegem, Antwerp, 2650, Belgium
Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology
Brussels, Brussels Capital, 1200, Belgium
UZ Gent - Pediatric Cardiology
Ghent, East Flanders, 9000, Belgium
UZ Leuven - Pediatric Cardiology
Leuven, Flemish Brabant, 3000, 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 | Cardiology
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
Royal University Hospital | Cardiology
Saskatoon, Saskatchewan, S7N 0W8, Canada
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Detské kardiocentrum 2. LF UK a FN Motol
Prague, Prague, 150 06, Czechia
Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinika
Brno, South Moravian, 613 00, Czechia
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia
Helsinki, Uusimaa, 00290, Finland
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene Herzfehler
Giessen, Hesse, 35385, Germany
Universitätsklinikum Köln - Kinderkardiologie
Cologne, North Rhine-Westphalia, 50937, 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
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
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Wroclaw, 51-124, Poland
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
Hospital de Santa Cruz | Pediatric Cardiology Department
Lisbon, 1449-005, Portugal
Unidade Local de Saúde de Santo António, E.P.E. - Centro Materno Infantil do Norte - Serviço de Cardiologia Pediátrica
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
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Guishan, Taoyuan, 83301, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 813414, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, 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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2025
First Posted
September 25, 2025
Study Start
June 1, 2026
Primary Completion (Estimated)
December 30, 2030
Study Completion (Estimated)
December 30, 2030
Last Updated
June 29, 2026
Record last verified: 2026-06
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.