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
NCT ID: NCT07192952
Last Updated: 2026-01-09
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
117 participants
INTERVENTIONAL
2026-04-01
2030-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Finerenone Open-Label Safety Extension
Participants will receive finerenone treatment.
Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 270±7 days.
Interventions
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Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 270±7 days.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* For participants who received finerenone in FIORE: K+ \>5.5 mmol/ L
* For participants who received placebo in FIORE: K+ \>5.0 mmol/L for children ≥2 years of age, and \>5.3 mmol/L for children \<2 years of age (if eGFR is \<60 mL/min/1.73m² for participants \<2 years of age, the serum potassium threshold of \>5.0 mmol/L will be used for exclusion)
* For newly enrolled newborns and infants \< 6 months of age: Potassium ≥ 5.3 mmol/l (if eGFR is \<60 mL/min/1.73m², the serum potassium threshold of \>5.0 mmol/L will be used for exclusion).
* 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.
18 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 - 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 | Pediatric Nephrology 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
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-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia
Helsinki, , 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
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
Department of Cardiology - Research Unit
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, , 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
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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2024-519830-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
21467
Identifier Type: -
Identifier Source: org_study_id
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