RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Bayer • ClinicalTrials.gov ID: NCT07188805

Registry updated: 2026-10-15

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Description

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.

Interventions

Finerenone (Kerendia, BAY94-8862) (Drug)
Finerenone in different doses, treatment duration will be 90±3 days
Placebo (Drug)
Placebo to finerenone, treatment duration will be 90±3 days

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Serum/plasma potassium (based on local laboratory results): * \> 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 randomization visit based on local laboratory results. * 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.

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 de Pediatría Juan P. Garrahan — 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
Hospital General de Ninos Ricardo Gutierrez | Cardiology 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 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
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 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
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 ?OOD 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 Brno, Detská nemocnice - Pediatrická klinika — Brno, Czechia
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Detské kardiocentrum 2. LF UK a FN Motol — Prague, Czechia
Oulu University Hospital, Oulun yliopistollinen sairaala (OYS) - Lasten ja nuorten palvelut — Oulu, North Ostrobothnia, Finland
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia — Helsinki, Uusimaa, 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, 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, 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
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego 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
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 — Carnaxide, 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 Reina Sofia | Cardiologia pediatrica — Córdoba, Córdoba, Spain
Hospital Universitario Ramon Y Cajal | Cardiologia pediatrica — Madrid, Madrid, Spain
Hospital Universitario Regional De Malaga | Cardiologia pediatrica — Málaga, Málaga, Spain
Hospital Universitario Virgen Del Rocio S.L. | Cardiologia pediatrica — Seville, Sevilla, Spain
Hospital Universitari Vall D Hebron | Cardiologia pediatrica — Barcelona, Spain
Hospital Universitario 12 De Octubre | Cardiologia pediatrica — Madrid, Spain
Hospital Universitario La Paz | Cardiologia pediatrica — Madrid, Spain
Skånes Universitetssjukhus - Lund - Barnhjärtcentrum — Lund, Skåne County, Sweden
Kaohsiung Veterans General Hospital — Kaohsiung City, Kaohsiung, Taiwan
Chang Gung Memorial Hospital Kaohsiung — 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
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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