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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
NCT07192952 · Bayer
In plain English
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Official title
A Phase 3, Single-arm, Open-label Extension Study to Evaluate the Safety of Finerenone in Addition to Standard of Care, in Pediatric Heart Failure Patients, From Birth to 18 Years of Age, With Left Ventricular Systolic Dysfunction (LVSD)
About this study
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.
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 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.
Study design
Enrollment target: 117 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2026-06-01
Estimated completion: 2030-12-30
Last updated: 2026-06-05
Interventions
Drug: Finerenone (Kerendia, BAY94-8862)
Primary outcomes
- • Number of participants with treatment-emergent adverse events (TEAEs) (From the start of study intervention to last study intervention (up to 277 days) + 3 days)
- • Change in serum potassium levels (From baseline to Day 270±7)
- • Change in systolic blood pressure (SBP) (From baseline to Day 270±7)
Sponsor
Bayer · industry
Contacts & investigators
ContactBayer Clinical Trials Contact · contact · clinical-trials-contact@bayer.com · (+)1-888-84 22937
All locations (132)
Children's Hospital Colorado - Anschutz Medical Campus - CardiologyNot Yet Recruiting
Aurora, Colorado, United States
Nemours Children's Hospital - Delaware - CardiologyNot Yet Recruiting
Wilmington, Delaware, United States
UF Health Shands Hospital - Pediatric CardiologyNot Yet Recruiting
Gainesville, Florida, United States
Joe Dimaggio Children's Hospital - CardiologyNot Yet Recruiting
Hollywood, Florida, United States
Emory University Hospital - Children's Healthcare of Atlanta Cardiology - AtlantaNot Yet Recruiting
Atlanta, Georgia, United States
Riley Hospital For Children - CardiologyNot Yet Recruiting
Indianapolis, Indiana, United States
Boston Children's Hospital - Main Campus - CardiologyNot Yet Recruiting
Boston, Massachusetts, United States
C.S. Mott Children's Hospital - CardiologyNot Yet Recruiting
Ann Arbor, Michigan, United States
Children's Mercy Hospital Kansas City - CardiologyNot Yet Recruiting
Kansas City, Missouri, United States
Washington University - St. Louis Children's Hospital - CardiologyNot Yet Recruiting
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai - Pediatric CardiologyNot Yet Recruiting
New York, New York, United States
Columbia University Irving Medical Center - Pediatric CardiologyNot Yet Recruiting
New York, New York, United States
The Children's Hospital at Montefiore - CardiologyNot Yet Recruiting
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center | Division of Nephrology and HypertensionNot Yet Recruiting
Cincinnati, Ohio, United States
Cleveland Clinic Children'sNot Yet Recruiting
Cleveland, Ohio, United States
Nationwide Children's Hospital - CardiologyNot Yet Recruiting
Columbus, Ohio, United States
Children's Hospital of Philadelphia - CardiologyNot Yet Recruiting
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh - CardiologyNot Yet Recruiting
Pittsburgh, Pennsylvania, United States
MUSC Shawn Jenkins Children's Hospital - CardiologyNot Yet Recruiting
North Charleston, South Carolina, United States
Children's Medical Center Dallas - CardiologyNot Yet Recruiting
Dallas, Texas, United States
Texas Children's Hospital - CardiologyNot Yet Recruiting
Houston, Texas, United States
Eccles Primary Children's Outpatient Services - CardiologyNot Yet Recruiting
Salt Lake City, Utah, United States
Hospital de Niños Sor María LudovicaNot Yet Recruiting
La Plata, Buenos Aires, Argentina
Instituto De Investigaciones Clinicas Zarate | Zarate, ArgentinaNot Yet Recruiting
Zárate, Buenos Aires, Argentina
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios ClinicosNot Yet Recruiting
Rosario, Santa Fe Province, Argentina
Hospital Italiano de Buenos AiresNot Yet Recruiting
Buenos Aires, Argentina
Hospital de Pediatría Juan P. GarrahanNot Yet Recruiting
Buenos Aires, Argentina
Hospital General de Ninos Pedro de Elizalde | Nephrology DepartmentNot Yet Recruiting
Buenos Aires, Argentina
Hospital General de Ninos Ricardo Gutierrez | Cardiology DepartmentNot Yet Recruiting
Ciudad Autónoma de Buenos Aire, Argentina
Consultorios Médicos Dr. DoreskiNot Yet Recruiting
Ciudad Autónoma de Buenos Aire, Argentina
Sanatorio de la CañadaNot Yet Recruiting
Córdoba, Argentina
Centro Cardiovascular Salta (Torzav SRL)Not Yet Recruiting
Salta, Argentina
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische KardiologieNot Yet Recruiting
Vienna, State of Vienna, Austria
Kepler Universitätsklinikum GmbH - Klinik für KinderkardiologieNot Yet Recruiting
Innsbruck, Upper Austria, Austria
UZ Leuven - Pediatric CardiologyNot Yet Recruiting
Leuven, Flemish Brabant, Belgium
Cliniques Universitaires St-Luc (UCL) - Pediatric CardiologyNot Yet Recruiting
Brussels, Belgium
UZ Antwerpen - Pediatric CardiologyNot Yet Recruiting
Edegem, Belgium
UZ Gent - Pediatric CardiologyNot Yet Recruiting
Ghent, Belgium
CHC MontLegia - Pediatric CardiologyNot Yet Recruiting
Liège, Belgium
Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares - EBSERHWithdrawn
Uberlândia, Minas Gerais, Brazil
Hospital Pequeno PrincipeNot Yet Recruiting
Curitiba, Paraná, Brazil
Centro de Pesquisa Clinica e Populacional HospitalizeNot Yet Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Universidade de Caxias do SulNot Yet Recruiting
Marília, São Paulo, Brazil
Liga Alvaro Bahia Contra a Mortalidade Infantil - Hospital Martagão GesteiraNot Yet Recruiting
Salvador, São Paulo, Brazil
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde InfantilNot Yet Recruiting
São Paulo, São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia | Divisao de PesquisaNot Yet Recruiting
São Paulo, São Paulo, Brazil
Campinas Clinical Research Institute (IPECC) | Campinas, BrazilNot Yet Recruiting
São Paulo, São Paulo, Brazil
Santa Casa de Misericórdia de Belo HorizonteNot Yet Recruiting
São Paulo, São Paulo, Brazil
InCor HCFMUSPNot Yet Recruiting
São Paulo, São Paulo, Brazil
University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric ClinicNot Yet Recruiting
Plovdiv, Plovdiv Province, Bulgaria
National Heart Hospital (NHH) - Dept. Pediatric CardiologyNot Yet Recruiting
Sofia, Sofia City Province, Bulgaria
Medical Center Nora- Heart ?OOD Child CardiologyNot Yet Recruiting
Sofia, Sofia City Province, Bulgaria
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, SofiaNot Yet Recruiting
Sofia, Sofia City Province, Bulgaria
Stollery Children's Hospital | CardiologyNot Yet Recruiting
Edmonton, Alberta, Canada
BC Children's Hospital | Children's Heart CentreWithdrawn
Vancouver, British Columbia, Canada
Children's Hospital | CardiologyNot Yet Recruiting
London, Ontario, Canada
The Hospital for Sick Children (SickKids)Not Yet Recruiting
Toronto, Ontario, Canada
Centre hospitalier universitaire Sainte-Justine | CardiologyNot Yet Recruiting
Montreal, Quebec, Canada
Royal University Hospital | CardiologyNot Yet Recruiting
Saskatoon, Saskatchewan, Canada
Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinikaNot Yet Recruiting
Brno, Czechia
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Detské kardiocentrum 2. LF UK a FN MotolNot Yet Recruiting
Prague, Czechia
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologiaNot Yet Recruiting
Helsinki, Uusimaa, Finland
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene HerzfehlerNot Yet Recruiting
Giessen, Hesse, Germany
Universitätsklinikum Köln - KinderkardiologieWithdrawn
Cologne, Germany
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, IntensivmedizinNot Yet Recruiting
Tübingen, Germany
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart DiseaseNot Yet Recruiting
Kallithea, Attica, Greece
Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of PediatricsNot Yet Recruiting
Athens, Greece
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology DepartmentNot Yet Recruiting
Athens, Greece
Nosokomeio Paidon I Agia Sofia, Cardiology DepartmentNot Yet Recruiting
Athens, Greece
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet - Gyermeksziv KozpontNot Yet Recruiting
Budapest, Hungary
Rambam Health CorporationWithdrawn
Haifa, Israel
Edith Wolfson Medical Center (EWMC)Not Yet Recruiting
Holon, Israel
Shaare Zedek Medical CenterNot Yet Recruiting
Jerusalem, Israel
Dana-Dwek Children's HospitalNot Yet Recruiting
Tel Aviv, Israel
Chaim Sheba Medical CenterNot Yet Recruiting
Tel Litwinsky, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adultoNot Yet Recruiting
Bergamo, Italy
Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutivaNot Yet Recruiting
Bologna, Italy
IRCCS Istituto Giannina Gaslini - CardiologiaNot Yet Recruiting
Genova, Italy
ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatricaNot Yet Recruiting
Milan, Italy
Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche CardiovascolariNot Yet Recruiting
Naples, Italy
Azienda Ospedale-Università di Padova - UOC Cardiologia PediatricaNot Yet Recruiting
Padova, Italy
Ospedale Pediatrico Bambino Gesù - Unità Terapie Cardiovascolari AvanzateNot Yet Recruiting
Roma, Italy
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatricaNot Yet Recruiting
Torino, Italy
Centro de Investigación Clínica Médica y Farmacológica S.A de C.VNot Yet Recruiting
Guadalajara, Jalisco, Mexico
Hospital Infantil de México "Dr. Federico Gómez"Withdrawn
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-PediatriaNot Yet Recruiting
Monterrey, Nuevo León, Mexico
Invecordis Sc.Not Yet Recruiting
Huixquilucan, State of Mexico, Mexico
Centro de Estudios de Investigacion Metabolicos y CardiovascularesNot Yet Recruiting
Ciudad Madero, Tamaulipas, Mexico
Centro de Estudios Clínicos de Querétaro S.C.Not Yet Recruiting
Querétaro, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí S.C.Not Yet Recruiting
San Luis Potosí City, Mexico
Instituto Nacional de Cardiología "Ignacio Chávez"Not Yet Recruiting
Tlalpan, Mexico
Pomnik Centrum Zdrowia Dziecka - Klinika KardiologiiWithdrawn
Warsaw, Masovian Voivodeship, Poland
Górnoslaskie Centrum Zdrowia Dziecka im. sw. Jana Pawla II SPSK Nr 6 Slaskiego UM w Katowicach - Oddzial Kardiologii DzieciecejNot Yet Recruiting
Katowice, Poland
Instytut Centrum Zdrowia Matki Polki w Lodzi - Klinika KardiologiiWithdrawn
Lódz, Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We WroclawiuNot Yet Recruiting
Wroclaw, Poland
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia PediátricaNot Yet Recruiting
Coimbra, Portugal
Hospital Santa Marta | Pediatric Cardiology DepartmentNot Yet Recruiting
Lisbon, Portugal
Hospital de Santa Cruz | Pediatric Cardiology DepartmentNot Yet Recruiting
Lisbon, Portugal
Unidade Local de Saúde de Santo António, E.P.E. - Centro Materno Infantil do Norte - Serviço de Cardiologia PediátricaNot Yet Recruiting
Porto, Portugal
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de PediatriaNot Yet Recruiting
Porto, Portugal
Pusan National University Yangsan Children's HospitalNot Yet Recruiting
Yangsan, Gyeongsangnam-do, South Korea
Seoul National University Hospital-Pediatrics DepartmentNot Yet Recruiting
Jongno, Seoul, South Korea
Severance Hospital, Yonsei University Health System-Pediatrics DepartmentNot Yet Recruiting
Seodaemun, South Korea
Samsung Medical Center-PediatricsNot Yet Recruiting
Seoul, South Korea
Hospital Sant Joan De Deu Barcelona | Cardiologia pediatricaNot Yet Recruiting
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitari Vall D Hebron | Cardiologia pediatricaNot Yet Recruiting
Barcelona, Spain
Hospital Universitario Reina Sofia | Cardiologia pediatricaNot Yet Recruiting
Córdoba, Spain
Hospital Universitario Ramon Y Cajal | Cardiologia pediatricaWithdrawn
Madrid, Spain
Hospital Universitario 12 De Octubre | Cardiologia pediatricaNot Yet Recruiting
Madrid, Spain
Hospital Universitario La Paz | Cardiologia pediatricaNot Yet Recruiting
Madrid, Spain
Hospital Universitario Regional De Malaga | Cardiologia pediatricaNot Yet Recruiting
Málaga, Spain
Hospital Universitario Virgen Del Rocio S.L. | Cardiologia pediatricaNot Yet Recruiting
Seville, Spain
Skånes Universitetssjukhus - Lund - BarnhjärtcentrumNot Yet Recruiting
Lund, Skåne County, Sweden
Chang Gung Memorial Hospital (CGMH) - Kaohsiung BranchNot Yet Recruiting
Guishan, Taoyuan, Taiwan
Kaohsiung Veterans General HospitalNot Yet Recruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalNot Yet Recruiting
Tainan, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
MacKay Children's hospitalNot Yet Recruiting
Taipei, Taiwan
Cukurova Universitesi Tip Fakultesi HastanesiNot Yet Recruiting
Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip FakultesiNot Yet Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir HastanesiNot Yet Recruiting
Bilkent Ankara, Turkey (Türkiye)
Marmara Uni. Tip Fak. Pendik EAH KardiyolojiNot Yet Recruiting
Istanbul, Turkey (Türkiye)
Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.Not Yet Recruiting
Istanbul, Turkey (Türkiye)
Izmir Dr. Behcet Uz Cocuk Hastaliklari HastNot Yet Recruiting
Izmir, Turkey (Türkiye)
University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research FacilityNot Yet Recruiting
Leicester, Leicestershire, United Kingdom
Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research FacilityNot Yet Recruiting
Liverpool, Merseyside, United Kingdom
Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric CardiologyNot Yet Recruiting
Belfast, Northern Ireland, United Kingdom
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research FacilityNot Yet Recruiting
Glasgow, Scotland, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart UnitNot Yet Recruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research FacilityNot Yet Recruiting
Leeds, West Yorkshire, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research FacilityNot Yet Recruiting
Bristol, United Kingdom