RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Bayer • ClinicalTrials.gov ID: NCT07192952

Registry updated: 2026-10-15

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Description

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.

Interventions

Finerenone (Kerendia, BAY94-8862) (Drug)
Finerenone in different doses, treatment duration will be 270±7 days.

Eligibility criteria

Inclusion Criteria: * 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 ng/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 rolling over from randomized controlled trial (RCT): To roll-over to FIORELLO, all participants: Potassium (K+) \>5.5 mmol/L based on local laboratory results. After unblinding: * 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 based on local laboratory results at FIORELLO 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.

Conditions

Left Ventricular Systolic Dysfunction Heart Failure (Pediatric)

Locations

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 Italiano de Buenos Aires — Buenos Aires, Buenos Aires, Argentina
Hospital de Pediatría Juan P. Garrahan — Buenos Aires, Buenos Aires, Argentina
Hospital General de Ninos Pedro de Elizalde | Nephrology Department — Buenos Aires, Buenos Aires, Argentina
Consultorios Médicos Dr. Doreski — 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
Sanatorio de la Cañada — Córdoba, Córdoba Province, Argentina
Centro Cardiovascular Salta (Torzav SRL) — Salta, Salta Province, Argentina
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos — Rosario, Santa Fe Province, Argentina
Hospital General de Ninos Ricardo Gutierrez | Cardiology Department — Ciudad Autónoma de Buenos Aire, 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 Antwerpen - Pediatric Cardiology — Edegem, Antwerp, Belgium
Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology — Brussels, Brussels Capital, Belgium
UZ Gent - Pediatric Cardiology — Ghent, East Flanders, Belgium
UZ Leuven - Pediatric Cardiology — Leuven, Flemish Brabant, Belgium
CHC MontLegia - Pediatric Cardiology — Liège, 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 EOOD 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 Motol a Homolka, Pracovište MOTOL - Detské kardiocentrum 2. LF UK a FN Motol — Prague, Prague, Czechia
Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinika — Brno, South Moravian, Czechia
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia — Helsinki, Uusimaa, Finland
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin — Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene Herzfehler — Giessen, Hesse, Germany
Universitätsklinikum Köln - Kinderkardiologie — Cologne, North Rhine-Westphalia, 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, 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
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
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu — Wroclaw, 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 — Lisbon, Lisbon District, Portugal
Unidade Local de Saúde de Santo António, E.P.E. - Centro Materno Infantil do Norte - Serviço de Cardiologia Pediátrica — Porto, Portugal
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Pediatria — 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 Universitario Regional De Malaga | Cardiologia pediatrica — Málaga, Málaga, 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 Virgen Del Rocio S.L. | Cardiologia pediatrica — Seville, Spain
Skånes Universitetssjukhus - Lund - Barnhjärtcentrum — Lund, Skåne County, Sweden
Kaohsiung Veterans General Hospital — Kaohsiung City, Kaohsiung, Taiwan
Taichung Veterans General Hospital — Taichung, Taichung, Taiwan
National Cheng Kung University Hospital — Tainan, Tainan, Taiwan
National Taiwan University Hospital — Taipei, Taipei, Taiwan
MacKay Children's hospital — Taipei, Taipei, Taiwan
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch — Guishan, Taoyuan, 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 Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility — Bristol, Bristol, United Kingdom
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

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