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Recruiting Phase 3 NCT07188805

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

Phase 3 – large-scale trial before approval
Conditions: Left Ventricular Systolic Dysfunction Heart Failure (Pediatric)

Sponsor: Bayer

trial.available_in: БГ
Overview
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.
Who can participate
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 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.
Interventions
Finerenone (Kerendia, BAY94-8862)
DRUG
Placebo
DRUG
Locations 133
Argentina (10)
Hospital General de Ninos Ricardo Gutierrez | Cardiology Department
Buenos Aires , Ciudad Auton. de Buenos Aires
NOT_YET_RECRUITING
Hospital Italiano de Buenos Aires
Buenos Aires
NOT_YET_RECRUITING
Hospital de Pediatría Juan P. Garrahan
Buenos Aires
NOT_YET_RECRUITING
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Ciudad Autonoma de Buenos Aire
NOT_YET_RECRUITING
Consultorios Médicos Dr. Doreski
Ciudad Autónoma de Buenos Aire
NOT_YET_RECRUITING
Sanatorio de la Cañada
Córdoba
NOT_YET_RECRUITING
Hospital de Niños Sor María Ludovica
La Plata , Buenos Aires
NOT_YET_RECRUITING
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos
Rosario , Santa Fe Province
NOT_YET_RECRUITING
Centro Cardiovascular Salta (Torzav SRL)
Salta
NOT_YET_RECRUITING
Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina
Zárate , Buenos Aires
Austria (2)
Kepler Universitätsklinikum GmbH - Klinik für Kinderkardiologie
Innsbruck , Upper Austria
NOT_YET_RECRUITING
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie
Vienna , State of Vienna
NOT_YET_RECRUITING
Belgium (5)
Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology
Brussels
UZ Antwerpen - Pediatric Cardiology
Edegem
NOT_YET_RECRUITING
UZ Gent - Pediatric Cardiology
Ghent
NOT_YET_RECRUITING
UZ Leuven - Pediatric Cardiology
Leuven , Flemish Brabant
NOT_YET_RECRUITING
CHC MontLegia - Pediatric Cardiology
Liège
NOT_YET_RECRUITING
Brazil (10)
Hospital Pequeno Principe
Curitiba , Paraná
Fundação Universidade de Caxias do Sul
Marília , São Paulo
NOT_YET_RECRUITING
Centro de Pesquisa Clinica e Populacional Hospitalize
Porto Alegre , Rio Grande do Sul
NOT_YET_RECRUITING
Liga Alvaro Bahia Contra a Mortalidade Infantil - Hospital Martagão Gesteira
Salvador , São Paulo
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
São Paulo , São Paulo
NOT_YET_RECRUITING
Instituto Dante Pazzanese de Cardiologia | Divisao de Pesquisa
São Paulo , São Paulo
NOT_YET_RECRUITING
Campinas Clinical Research Institute (IPECC) | Campinas, Brazil
São Paulo , São Paulo
NOT_YET_RECRUITING
Santa Casa de Misericórdia de Belo Horizonte
São Paulo , São Paulo
NOT_YET_RECRUITING
InCor HCFMUSP
São Paulo , São Paulo
NOT_YET_RECRUITING
Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares - EBSERH
Uberlândia , Minas Gerais
NOT_YET_RECRUITING
Bulgaria (4)
University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric Clinic
Plovdiv , Plovdiv Province
NOT_YET_RECRUITING
National Heart Hospital (NHH) - Dept. Pediatric Cardiology
Sofia , Sofia City Province
NOT_YET_RECRUITING
Medical Center Nora- Heart ?OOD Child Cardiology
Sofia , Sofia City Province
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
Sofia , Sofia City Province
NOT_YET_RECRUITING
Canada (6)
Stollery Children's Hospital (SCH)
Edmonton , Alberta
NOT_YET_RECRUITING
Children's Hospital | Cardiology
London , Ontario
NOT_YET_RECRUITING
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal , Quebec
NOT_YET_RECRUITING
University of Saskatchewan, Royal University Hospital
Saskatoon , Saskatchewan
NOT_YET_RECRUITING
The Hospital for Sick Children (SickKids)
Toronto , Ontario
NOT_YET_RECRUITING
BC Children's Hospital | Children's Heart Centre
Vancouver , British Columbia
WITHDRAWN
Czech Republic (2)
Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinika
Brno
NOT_YET_RECRUITING
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Detské kardiocentrum 2. LF UK a FN Motol
Prague
NOT_YET_RECRUITING
Finland (2)
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia
Helsinki , Uusimaa
NOT_YET_RECRUITING
Oulu University Hospital, Oulun yliopistollinen sairaala (OYS) - Lasten ja nuorten palvelut
Oulu , North Ostrobothnia
WITHDRAWN
Germany (3)
Universitätsklinikum Köln - Kinderkardiologie
Cologne
NOT_YET_RECRUITING
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene Herzfehler
Giessen , Hesse
NOT_YET_RECRUITING
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin
Tübingen
NOT_YET_RECRUITING
Greece (4)
Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics
Athens
NOT_YET_RECRUITING
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department
Athens
NOT_YET_RECRUITING
Nosokomeio Paidon I Agia Sofia, Cardiology Department
Athens
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart Disease
Kallithea , Attica
NOT_YET_RECRUITING
Hungary (1)
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet - Gyermeksziv Kozpont
Budapest
NOT_YET_RECRUITING
Israel (5)
Rambam Health Corporation
Haifa
SUSPENDED
Edith Wolfson Medical Center (EWMC)
Holon
NOT_YET_RECRUITING
Shaare Zedek Medical Center
Jerusalem
NOT_YET_RECRUITING
Dana-Dwek Children's Hospital
Tel Aviv
NOT_YET_RECRUITING
Chaim Sheba Medical Center
Tel Litwinsky
NOT_YET_RECRUITING
Italy (8)
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adulto
Bergamo
NOT_YET_RECRUITING
Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutiva
Bologna
NOT_YET_RECRUITING
IRCCS Istituto Giannina Gaslini - Cardiologia
Genova
NOT_YET_RECRUITING
ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica
Milan
NOT_YET_RECRUITING
Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari
Naples
NOT_YET_RECRUITING
Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica
Padova
NOT_YET_RECRUITING
Ospedale Pediatrico Bambino Gesù - Unità Terapie Cardiovascolari Avanzate
Roma
NOT_YET_RECRUITING
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatrica
Torino
NOT_YET_RECRUITING
Mexico (8)
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero , Tamaulipas
NOT_YET_RECRUITING
Centro de Investigación Clínica Médica y Farmacológica S.A de C.V
Guadalajara , Jalisco
NOT_YET_RECRUITING
Invecordis Sc.
Huixquilucan , State of Mexico
NOT_YET_RECRUITING
Hospital Infantil de México "Dr. Federico Gómez"
Mexico City , Mexico City
WITHDRAWN
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria
Monterrey , Nuevo León
NOT_YET_RECRUITING
Centro de Estudios Clínicos de Querétaro S.C.
Querétaro
NOT_YET_RECRUITING
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City
NOT_YET_RECRUITING
Instituto Nacional de Cardiología "Ignacio Chávez"
Tlalpan
NOT_YET_RECRUITING
Poland (4)
Górnoslaskie Centrum Zdrowia Dziecka im. sw. Jana Pawla II SPSK Nr 6 Slaskiego UM w Katowicach - Oddzial Kardiologii Dzieciecej
Katowice
NOT_YET_RECRUITING
Instytut Centrum Zdrowia Matki Polki w Lodzi - Klinika Kardiologii
Lódz
WITHDRAWN
Pomnik Centrum Zdrowia Dziecka - Klinika Kardiologii
Warsaw , Masovian Voivodeship
WITHDRAWN
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw , Lower Silesian Voivodeship
NOT_YET_RECRUITING
Portugal (5)
Hospital de Santa Cruz | Pediatric Cardiology Department
Carnaxide
NOT_YET_RECRUITING
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia Pediátrica
Coimbra
NOT_YET_RECRUITING
Hospital Santa Marta | Pediatric Cardiology Department
Lisbon
Centro Materno infantil do Norte - Pediatric Cardiology
Porto
NOT_YET_RECRUITING
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Pediatria
Porto
NOT_YET_RECRUITING
South Korea (4)
Seoul National University Hospital-Pediatrics Department
Jongno , Seoul
NOT_YET_RECRUITING
Severance Hospital, Yonsei University Health System-Pediatrics Department
Seodaemun
NOT_YET_RECRUITING
Samsung Medical Center-Pediatrics
Seoul
Pusan National University Yangsan Children's Hospital
Yangsan , Gyeongsangnam-do
NOT_YET_RECRUITING
Spain (8)
Hospital Universitari Vall D Hebron | Cardiologia pediatrica
Barcelona
NOT_YET_RECRUITING
Hospital Universitario Reina Sofia | Cardiologia pediatrica
Córdoba
NOT_YET_RECRUITING
Hospital Sant Joan De Deu Barcelona | Cardiologia pediatrica
Esplugues de Llobregat , Barcelona
NOT_YET_RECRUITING
Hospital Universitario Ramon Y Cajal | Cardiologia pediatrica
Madrid
WITHDRAWN
Hospital Universitario 12 De Octubre | Cardiologia pediatrica
Madrid
NOT_YET_RECRUITING
Hospital Universitario La Paz | Cardiologia pediatrica
Madrid
NOT_YET_RECRUITING
Hospital Universitario Regional De Malaga | Cardiologia pediatrica
Málaga
NOT_YET_RECRUITING
Hospital Universitario Virgen Del Rocio S.L. | Cardiologia pediatrica
Seville
NOT_YET_RECRUITING
Sweden (1)
Skånes Universitetssjukhus Lund - Barnhjärtcentrum
Lund , Skåne County
NOT_YET_RECRUITING
Taiwan (6)
Kaohsiung Veterans General Hospital
Kaohsiung City
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City
NOT_YET_RECRUITING
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
NOT_YET_RECRUITING
National Taiwan University Hospital
Taipei
MacKay Children's hospital
Taipei
NOT_YET_RECRUITING
Turkey (6)
Cukurova Universitesi Tip Fakultesi Hastanesi
Adana
NOT_YET_RECRUITING
Hacettepe Universitesi Tip Fakultesi
Ankara
NOT_YET_RECRUITING
Ankara Bilkent Sehir Hastanesi
Bilkent Ankara
NOT_YET_RECRUITING
Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji
Istanbul
NOT_YET_RECRUITING
Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.
Istanbul
NOT_YET_RECRUITING
Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast
Izmir
NOT_YET_RECRUITING
United Kingdom (7)
Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology
Belfast , Northern Ireland
NOT_YET_RECRUITING
University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility
Bristol
NOT_YET_RECRUITING
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
Glasgow , Scotland
NOT_YET_RECRUITING
Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility
Leeds , West Yorkshire
NOT_YET_RECRUITING
University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility
Leicester , Leicestershire
Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility
Liverpool , Merseyside
Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit
Newcastle upon Tyne , Tyne and Wear
NOT_YET_RECRUITING
United States (22)
C.S. Mott Children's Hospital - Cardiology
Ann Arbor , Michigan
NOT_YET_RECRUITING
Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta
Atlanta , Georgia
NOT_YET_RECRUITING
Children's Hospital Colorado - Anschutz Medical Campus - Cardiology
Aurora , Colorado
NOT_YET_RECRUITING
Boston Children's Hospital - Main Campus - Cardiology
Boston , Massachusetts
NOT_YET_RECRUITING
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Cincinnati , Ohio
NOT_YET_RECRUITING
Cleveland Clinic Children's
Cleveland , Ohio
NOT_YET_RECRUITING
Nationwide Children's Hospital - Cardiology
Columbus , Ohio
NOT_YET_RECRUITING
Children's Medical Center Dallas - Cardiology
Dallas , Texas
NOT_YET_RECRUITING
UF Health Shands Hospital - Pediatric Cardiology
Gainesville , Florida
NOT_YET_RECRUITING
Joe Dimaggio Children's Hospital - Cardiology
Hollywood , Florida
NOT_YET_RECRUITING
Texas Children's Hospital - Cardiology
Houston , Texas
NOT_YET_RECRUITING
Riley Hospital For Children - Cardiology
Indianapolis , Indiana
NOT_YET_RECRUITING
Children's Mercy Hospital Kansas City - Cardiology
Kansas City , Missouri
NOT_YET_RECRUITING
Icahn School of Medicine at Mount Sinai - Pediatric Cardiology
New York , New York
NOT_YET_RECRUITING
Columbia University Irving Medical Center - Pediatric Cardiology
New York , New York
NOT_YET_RECRUITING
MUSC Shawn Jenkins Children's Hospital - Cardiology
North Charleston , South Carolina
NOT_YET_RECRUITING
Children's Hospital of Philadelphia - Cardiology
Philadelphia , Pennsylvania
NOT_YET_RECRUITING
UPMC Children's Hospital of Pittsburgh - Cardiology
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
Eccles Primary Children's Outpatient Services - Cardiology
Salt Lake City , Utah
NOT_YET_RECRUITING
Washington University - St. Louis Children's Hospital - Cardiology
St Louis , Missouri
NOT_YET_RECRUITING
The Children's Hospital at Montefiore - Cardiology
The Bronx , New York
NOT_YET_RECRUITING
Nemours Children's Hospital - Delaware - Cardiology
Wilmington , Delaware
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Months
Maximum age
17 Years
Healthy volunteers
No
Start date
19.11.2025
Completion date
30.12.2029
Registry ID
NCT07188805
Source
clinicaltrials.gov
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