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Not yet recruiting Phase 3 NCT07192952

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

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 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.
Who can participate
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 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 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 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.
Interventions
Finerenone (Kerendia, BAY94-8862)
DRUG
Locations 132
Argentina (10)
Hospital Italiano de Buenos Aires
Buenos Aires
Hospital de Pediatría Juan P. Garrahan
Buenos Aires
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Buenos Aires
Hospital General de Ninos Ricardo Gutierrez | Cardiology Department
Ciudad Autónoma de Buenos Aire
Consultorios Médicos Dr. Doreski
Ciudad Autónoma de Buenos Aire
Sanatorio de la Cañada
Córdoba
Hospital de Niños Sor María Ludovica
La Plata , Buenos Aires
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos
Rosario , Santa Fe Province
Centro Cardiovascular Salta (Torzav SRL)
Salta
Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina
Zárate , Buenos Aires
Austria (2)
Kepler Universitätsklinikum GmbH - Klinik für Kinderkardiologie
Innsbruck , Upper Austria
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie
Vienna , State of Vienna
Belgium (5)
Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology
Brussels
UZ Antwerpen - Pediatric Cardiology
Edegem
UZ Gent - Pediatric Cardiology
Ghent
UZ Leuven - Pediatric Cardiology
Leuven , Flemish Brabant
CHC MontLegia - Pediatric Cardiology
Liège
Brazil (10)
Hospital Pequeno Principe
Curitiba , Paraná
Fundação Universidade de Caxias do Sul
Marília , São Paulo
Centro de Pesquisa Clinica e Populacional Hospitalize
Porto Alegre , Rio Grande do Sul
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
Instituto Dante Pazzanese de Cardiologia | Divisao de Pesquisa
São Paulo , São Paulo
Campinas Clinical Research Institute (IPECC) | Campinas, Brazil
São Paulo , São Paulo
Santa Casa de Misericórdia de Belo Horizonte
São Paulo , São Paulo
InCor HCFMUSP
São Paulo , São Paulo
Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares - EBSERH
Uberlândia , Minas Gerais
Bulgaria (4)
University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric Clinic
Plovdiv , Plovdiv Province
National Heart Hospital (NHH) - Dept. Pediatric Cardiology
Sofia , Sofia City Province
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
Canada (6)
Stollery Children's Hospital (SCH)
Edmonton , Alberta
Children's Hospital | Cardiology
London , Ontario
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal , Quebec
University of Saskatchewan, Royal University Hospital
Saskatoon , Saskatchewan
The Hospital for Sick Children (SickKids)
Toronto , Ontario
BC Children's Hospital | Children's Heart Centre
Vancouver , British Columbia
Czech Republic (2)
Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinika
Brno
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Detské kardiocentrum 2. LF UK a FN Motol
Prague
Finland (1)
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia
Helsinki , Uusimaa
Germany (3)
Universitätsklinikum Köln - Kinderkardiologie
Cologne
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene Herzfehler
Giessen , Hesse
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin
Tübingen
Greece (4)
Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics
Athens
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department
Athens
Nosokomeio Paidon I Agia Sofia, Cardiology Department
Athens
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart Disease
Kallithea , Attica
Hungary (1)
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet - Gyermeksziv Kozpont
Budapest
Israel (5)
Rambam Health Corporation
Haifa
Edith Wolfson Medical Center (EWMC)
Holon
Shaare Zedek Medical Center
Jerusalem
Dana-Dwek Children's Hospital
Tel Aviv
Chaim Sheba Medical Center
Tel Litwinsky
Italy (8)
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adulto
Bergamo
Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutiva
Bologna
IRCCS Istituto Giannina Gaslini - Cardiologia
Genova
ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica
Milan
Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari
Naples
Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica
Padova
Ospedale Pediatrico Bambino Gesù - Unità Terapie Cardiovascolari Avanzate
Roma
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatrica
Torino
Mexico (8)
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero , Tamaulipas
Centro de Investigación Clínica Médica y Farmacológica S.A de C.V
Guadalajara , Jalisco
Invecordis Sc.
Huixquilucan , State of Mexico
Hospital Infantil de México "Dr. Federico Gómez"
Mexico City , Mexico City
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria
Monterrey , Nuevo León
Centro de Estudios Clínicos de Querétaro S.C.
Querétaro
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City
Instituto Nacional de Cardiología "Ignacio Chávez"
Tlalpan
Poland (4)
Górnoslaskie Centrum Zdrowia Dziecka im. sw. Jana Pawla II SPSK Nr 6 Slaskiego UM w Katowicach - Oddzial Kardiologii Dzieciecej
Katowice
Instytut Centrum Zdrowia Matki Polki w Lodzi - Klinika Kardiologii
Lódz
Pomnik Centrum Zdrowia Dziecka - Klinika Kardiologii
Warsaw , Masovian Voivodeship
Wojewódzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo-Rozwojowy Oddzial Kardiologii Dzieciecej
Wroclaw
Portugal (5)
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia Pediátrica
Coimbra
Hospital Santa Marta | Pediatric Cardiology Department
Lisbon
Hospital de Santa Cruz | Pediatric Cardiology Department
Lisbon
Centro Materno infantil do Norte - Pediatric Cardiology
Porto
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Pediatria
Porto
South Korea (4)
Seoul National University Hospital-Pediatrics Department
Jongno , Seoul
Severance Hospital, Yonsei University Health System-Pediatrics Department
Seodaemun
Samsung Medical Center-Pediatrics
Seoul
Pusan National University Yangsan Children's Hospital
Yangsan , Gyeongsangnam-do
Spain (8)
Hospital Universitari Vall D Hebron | Cardiologia pediatrica
Barcelona
Hospital Universitario Reina Sofia | Cardiologia pediatrica
Córdoba
Hospital Sant Joan De Deu Barcelona | Cardiologia pediatrica
Esplugues de Llobregat , Barcelona
Hospital Universitario Ramon Y Cajal | Cardiologia pediatrica
Madrid
Hospital Universitario 12 De Octubre | Cardiologia pediatrica
Madrid
Hospital Universitario La Paz | Cardiologia pediatrica
Madrid
Hospital Universitario Regional De Malaga | Cardiologia pediatrica
Málaga
Hospital Universitario Virgen Del Rocio S.L. | Cardiologia pediatrica
Seville
Sweden (1)
Skånes Universitetssjukhus Lund - Barnhjärtcentrum
Lund , Skåne County
Taiwan (6)
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Guishan , Taoyuan
Kaohsiung Veterans General Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
MacKay Children's hospital
Taipei
Turkey (6)
Cukurova Universitesi Tip Fakultesi Hastanesi
Adana
Hacettepe Universitesi Tip Fakultesi
Ankara
Ankara Bilkent Sehir Hastanesi
Bilkent Ankara
Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji
Istanbul
Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.
Istanbul
Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast
Izmir
United Kingdom (7)
Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology
Belfast , Northern Ireland
University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility
Bristol
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
Glasgow , Scotland
Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility
Leeds , West Yorkshire
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
United States (22)
C.S. Mott Children's Hospital - Cardiology
Ann Arbor , Michigan
Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta
Atlanta , Georgia
Children's Hospital Colorado - Anschutz Medical Campus - Cardiology
Aurora , Colorado
Boston Children's Hospital - Main Campus - Cardiology
Boston , Massachusetts
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Cincinnati , Ohio
Cleveland Clinic Children's
Cleveland , Ohio
Nationwide Children's Hospital - Cardiology
Columbus , Ohio
Children's Medical Center Dallas - Cardiology
Dallas , Texas
UF Health Shands Hospital - Pediatric Cardiology
Gainesville , Florida
Joe Dimaggio Children's Hospital - Cardiology
Hollywood , Florida
Texas Children's Hospital - Cardiology
Houston , Texas
Riley Hospital For Children - Cardiology
Indianapolis , Indiana
Children's Mercy Hospital Kansas City - Cardiology
Kansas City , Missouri
Icahn School of Medicine at Mount Sinai - Pediatric Cardiology
New York , New York
Columbia University Irving Medical Center - Pediatric Cardiology
New York , New York
MUSC Shawn Jenkins Children's Hospital - Cardiology
North Charleston , South Carolina
Children's Hospital of Philadelphia - Cardiology
Philadelphia , Pennsylvania
UPMC Children's Hospital of Pittsburgh - Cardiology
Pittsburgh , Pennsylvania
Eccles Primary Children's Outpatient Services - Cardiology
Salt Lake City , Utah
Washington University - St. Louis Children's Hospital - Cardiology
St Louis , Missouri
The Children's Hospital at Montefiore - Cardiology
The Bronx , New York
Nemours Children's Hospital - Delaware - Cardiology
Wilmington , Delaware
Technical details
Status
Not yet recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Maximum age
18 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
30.12.2030
Registry ID
NCT07192952
Source
clinicaltrials.gov
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