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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
NCT07188805 · Bayer
In plain English
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Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Investigate the Efficacy, Safety, and PK/ PD of Finerenone, in Addition to Standard-of-care, in Pediatric Patients, 6 Months to < 18 Years of Age With Heart Failure (HF) and Left Ventricular Systolic Dysfunction (LVSD)
About this study
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.
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 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.
Study design
Enrollment target: 111 participants
Allocation: randomized
Masking: triple
Age groups: child
Timeline
Starts: 2025-11-19
Estimated completion: 2029-12-30
Last updated: 2026-05-18
Interventions
Drug: Finerenone (Kerendia, BAY94-8862)Drug: Placebo
Primary outcomes
- • Change in NT-proBNP levels (From baseline to Day 90±3)
Sponsor
Bayer · industry
Contacts & investigators
ContactBayer Clinical Trials Contact · contact · clinical-trials-contact@bayer.com · (+)1-888-84 22937
All locations (133)
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, ArgentinaRecruiting
Zárate, Buenos Aires, Argentina
Hospital General de Ninos Ricardo Gutierrez | Cardiology DepartmentNot Yet Recruiting
Buenos Aires, Ciudad Auton. de 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
Ciudad Autonoma 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 CardiologyRecruiting
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 - EBSERHNot Yet Recruiting
Uberlândia, Minas Gerais, Brazil
Hospital Pequeno PrincipeRecruiting
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 GesteiraRecruiting
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 CardiologyRecruiting
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
Oulu University Hospital, Oulun yliopistollinen sairaala (OYS) - Lasten ja nuorten palvelutWithdrawn
Oulu, North Ostrobothnia, Finland
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 - KinderkardiologieNot Yet Recruiting
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 DepartmentRecruiting
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
Wojewodzki Szpital Specjalistyczny we WroclawiuNot Yet Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
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
Hospital de Santa Cruz | Pediatric Cardiology DepartmentNot Yet Recruiting
Carnaxide, Portugal
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia PediátricaNot Yet Recruiting
Coimbra, Portugal
Hospital Santa Marta | Pediatric Cardiology DepartmentRecruiting
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-PediatricsRecruiting
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
Kaohsiung Veterans General HospitalRecruiting
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital KaohsiungNot Yet Recruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalNot Yet Recruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
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 HastanesiRecruiting
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 FacilityRecruiting
Leicester, Leicestershire, United Kingdom
Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research FacilityRecruiting
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