pause_circle_filledNot Yet Recruiting
Left ventricular systolic dysfunction, Heart failure (Pediatric)
Bayer Identifier:
21466
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
2024-519829-38-00
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
6 - 17 YearsTrial summary
Enrollment Goal
111Trial Dates
September 2025 - December 2029Phase
Phase 3Could I Receive a placebo
YesProducts
Finerenone (BAY94-8862)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica | Padova, 35128, Italy |
Not yet recruiting | A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatrica | Torino, 10126, Italy |
Not yet recruiting | Ospedale Pediatrico Bambino Gesù - Unità Terapie Cardiovascolari Avanzate | Roma, 00165, Italy |
Not yet recruiting | IRCCS Istituto Giannina Gaslini - Cardiologia | Genova, 16147, Italy |
Not yet recruiting | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adulto | Bergamo, 24127, Italy |
Not yet recruiting | ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica | Milan, 20162, Italy |
Not yet recruiting | Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutiva | Bologna, 40138, Italy |
Not yet recruiting | Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari | Naples, 80131, Italy |
Not yet recruiting | Hospital Santa Marta | Pediatric Cardiology Department | Lisbon, 1169-024, Portugal |
Not yet recruiting | Hospital de Santa Cruz | Pediatric Cardiology Department | Carnaxide, 2790-134, Portugal |
Not yet recruiting | ULS São João - Pediatric Department | Porto, 4200-319, Portugal |
Not yet recruiting | Department of Cardiology - Research Unit | Coimbra, 3004-561, Portugal |
Not yet recruiting | Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet - Gyermeksziv Kozpont | Budapest, 1096, Hungary |
Not yet recruiting | Nosokomeio Paidon I Agia Sofia, Cardiology Department | Athens, 11527, Greece |
Not yet recruiting | Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department | Athens, 11527, Greece |
Not yet recruiting | Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart Disease | Kalithea, 17674, Greece |
Not yet recruiting | Pusan National University Yangsan Hospital | Yangsan-si, 50612, Korea,_republic_of |
Not yet recruiting | Samsung Medical Center - Oncology Department | Seoul, 06351, Korea,_republic_of |
Not yet recruiting | Seoul National University Children's Hospital (SNUCH) | Jongno, 03080, Korea,_republic_of |
Not yet recruiting | Severance Hospital (Yonsei University Medical Center) | Seodaemun, 03722, Korea,_republic_of |
Not yet recruiting | Fakultní nemocnice v Motole - Detské kardiocentrum 2. LF UK a FN Motol | Praha 5, 150 06, Czech Republic |
Not yet recruiting | Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie | Vienna, 1090, Austria |
Not yet recruiting | Kepler Universitätsklinikum GmbH - Klinik für Kinderkardiologie | Linz, 4020, Austria |
Not yet recruiting | Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene Herzfehler | Giessen, 35385, Germany |
Not yet recruiting | Universitätsklinikum Köln - Kinderkardiologie | Köln, 50937, Germany |
Not yet recruiting | Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin | Tübingen, 72076, Germany |
Not yet recruiting | Hospital Universitario Regional De Malaga - Cardiologia pediatrica | Malaga, 29010, Spain |
Not yet recruiting | Hospital de Sant Joan de Déu | Esplugues de LLobregat, 8950, Spain |
Not yet recruiting | Hospital Universitario 12 de Octubre | Madrid, 28041, Spain |
Not yet recruiting | Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) | Madrid, 28046, Spain |
Not yet recruiting | Hospital Universitario Ramon Y Cajal - Cardiologia pediatrica | Madrid, 28034, Spain |
Not yet recruiting | Hospital Universitario Reina Sofia - Cardiologia pediatrica | Córdoba, 14004, Spain |
Not yet recruiting | Hospital Universitario Virgen Del Rocio S.L. - Cardiologia pediatrica | Sevilla, 41013, Spain |
Not yet recruiting | Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinika | Brno, 613 00, Czech Republic |
Not yet recruiting | Chaim Sheba Medical Center | Tel Hashomer, 52621, Israel |
Not yet recruiting | Shaare Zedek Medical Center | Jerusalem, 9103102, Israel |
Not yet recruiting | Chang Gung Memorial Hospital Kaohsiung | Kaohsiung, 833, Taiwan |
Not yet recruiting | MacKay Children's hospital | Taipei, 104217, Taiwan |
Not yet recruiting | National Cheng Kung University Hospital | Tainan, 704, Taiwan |
Not yet recruiting | National Taiwan University Hospital | Taipei, 100225, Taiwan |
Not yet recruiting | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Not yet recruiting | Kaohsiung Veterans General Hospital | Kaohsiung City, 813414, Taiwan |
Not yet recruiting | Joe Dimaggio Children's Hospital - Cardiology | Hollywood, 33021, United States |
Not yet recruiting | Edith Wolfson Medical Center (EWMC) | Holon, 58100, Israel |
Not yet recruiting | Rambam Health Corporation | Haifa, 3109601????, Israel |
Not yet recruiting | Dana-Dwek Children’s Hospital | Tel-Aviv, 6423906, Israel |
Not yet recruiting | Instytut Centrum Zdrowia Matki Polki w Lodzi - Klinika Kardiologii | Lódz, 93-338, Poland |
Not yet recruiting | Górnoslaskie Centrum Zdrowia Dziecka im. sw. Jana Pawla II SPSK Nr 6 Slaskiego UM w Katowicach - Oddzial Kardiologii Dzieciecej | Katowice, 40-752, Poland |
Not yet recruiting | Pomnik Centrum Zdrowia Dziecka - Klinika Kardiologii | Warszawa, 04-730, Poland |
Not yet recruiting | Wojewodzki Szpital Specjalistyczny we Wroclawiu | Wroclaw, 51-124, Poland |
Not yet recruiting | London Health Sciences Centre - Children's Hospital | London, N6A 5W9, Canada |
Not yet recruiting | The Hospital for Sick Children (SickKids) | Toronto, M5G 1X8, Canada |
Not yet recruiting | CHU Sainte-Justine | Montreal, H3T 1C5, Canada |
Not yet recruiting | Ankara Bilkent Sehir Hastanesi | Bilkent ankara, 6800, Turkey |
Not yet recruiting | Hacettepe Universitesi Tip Fakultesi | Ankara, 6100, Turkey |
Not yet recruiting | Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H. | Istanbul, TBC, Turkey |
Not yet recruiting | Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji | Istanbul, 34899, Turkey |
Not yet recruiting | BC Children’s Hospital - Children's Heart Centre | Vancouver, V6H 3V4, Canada |
Not yet recruiting | Hospital Universitari Vall d´Hebron_ Nefrologia | Barcelona, 08035, Spain |
Not yet recruiting | CHC MontLegia - Pediatric Cardiology | Liège, 4000, Belgium |
Not yet recruiting | Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology | Brussels, 1200, Belgium |
Not yet recruiting | UZ Gent - Pediatric Cardiology | Gent, 9000, Belgium |
Not yet recruiting | UZ Leuven - Pediatric Cardiology | Leuven, 3000, Belgium |
Not yet recruiting | UZ Antwerpen - Pediatric Cardiology | Edegem, 2650, Belgium |
Not yet recruiting | National Heart Hospital (NHH) - Dept. Pediatric Cardiology | Sofia, 1309, Bulgaria |
Not yet recruiting | Fundação Universidade de Caxias do Sul | Caxias do Sul, 95070-560, Brazil |
Not yet recruiting | Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil | Sao Paulo, 01227-200, Brazil |
Not yet recruiting | Hospital Pequeno Principe | Curitiba, 80250-060, Brazil |
Not yet recruiting | InCor HCFMUSP | São Paulo, 5403000, Brazil |
Not yet recruiting | Instituto Dante Pazzanese de Cardiologia | Divisao de Pesquisa | São Paulo, 04012-180, Brazil |
Not yet recruiting | Campinas Clinical Research Institute (IPECC) | Campinas, Brazil | Campinas, 13060-080, Brazil |
Not yet recruiting | Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte, 30150-221, Brazil |
Not yet recruiting | Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares – EBSERH | Uberlandia, 38405-325, Brazil |
Not yet recruiting | IESG - Instituto de Ensino da Saude e Gestao | Salvador, 40050-050, Brazil |
Not yet recruiting | Centro de Pesquisa Clinica e Populacional Hospitalize | Porto Alegre, 90810-080, Brazil |
Not yet recruiting | Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology | Belfast, BT12 6BE, United Kingdom |
Not yet recruiting | NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility | Glasgow, G51 4TF, United Kingdom |
Not yet recruiting | Leeds Teaching Hospitals NHS Trust | Leeds Children’s Hospital - Children's Research Facility | Leeds, LS1 3EX, United Kingdom |
Not yet recruiting | Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit | Newcastle upon Tyne, NE7 7DN, United Kingdom |
Not yet recruiting | University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility | Bristol, BS2 8AE, United Kingdom |
Not yet recruiting | University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility | Leicester, LE1 5WW, United Kingdom |
Not yet recruiting | Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility | Liverpool, L122AP, United Kingdom |
Not yet recruiting | University of Saskatchewan, Royal University Hospital | Saskatoon, S7N 0W8, Canada |
Not yet recruiting | Centro Cardiovascular Salta (Torzav SRL) | Salta, A4406BPF, Argentina |
Not yet recruiting | Cukurova Universitesi Tip Fakultesi Hastanesi | Adana, 1330, Turkey |
Not yet recruiting | Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department | Buenos Aires, C1425EFD, Argentina |
Not yet recruiting | Hospital de Pediatría Juan P. Garrahan | Buenos Aires, C1249ABN, Argentina |
Not yet recruiting | Hospital General de Ninos Pedro de Elizalde | Nephrology Department | Ciudad Autonoma de Buenos Aire, C1270AAN, Argentina |
Not yet recruiting | Sanatorio de la Cañada | Cordoba, X5000BSQ, Argentina |
Not yet recruiting | Hospital Italiano de Buenos Aires | Buenos Aires, C1199ABB, Argentina |
Not yet recruiting | Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina | Zárate, B2800DGH, Argentina |
Not yet recruiting | Hospital de Niños Sor María Ludovica | La Plata, 1900, Argentina |
Not yet recruiting | Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos | Rosario, S2000DEJ, Argentina |
Not yet recruiting | Consultorios Médicos Dr. Doreski | Ciudad Autónoma de Buenos Aire, C1426ABP, Argentina |
Not yet recruiting | Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast | Izmir, 35210, Turkey |
Not yet recruiting | Centro de Estudios Clínicos de Querétaro S.C. | Querétaro, 76000, Mexico |
Not yet recruiting | Centro de Estudios de Investigacion Metabolicos y Cardiovasculares | Cd. Madero, C.P. 89440, Mexico |
Not yet recruiting | CINVEC Medica | Guadalajara, C.P.44690, Mexico |
Not yet recruiting | Hospital Infantil de México "Dr. Federico Gómez" | Ciudad de México, 6720, Mexico |
Not yet recruiting | Instituto Nacional de Cardiología "Ignacio Chávez" | Tlalpan, C.P. 14080, Mexico |
Not yet recruiting | University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia | Sofia, 1431, Bulgaria |
Not yet recruiting | University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric Clinic | Plovdiv, 4000, Bulgaria |
Not yet recruiting | Centro de Atención e Investigación Cardiovascular del Potosí S.C. | San Luis Potosí, 72300, Mexico |
Not yet recruiting | Hospital Angeles (HA)-Lomas | Huixquilucan, 52763, Mexico |
Not yet recruiting | Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria | Monterrey, C.P. 64460, Mexico |
Not yet recruiting | Skånes Universitetssjukhus Lund - Barnhjärtcentrum | Lund, 222 41, Sweden |
Not yet recruiting | HUS Uusi lastensairaala - Lasten kardiologian vastaanotot | Helsinki, 00290, Finland |
Not yet recruiting | Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics | Athens, 11527, Greece |
Not yet recruiting | Boston Children's Hospital - Main Campus - Cardiology | Boston, 02215, United States |
Not yet recruiting | Children's Hospital Colorado - Anschutz Medical Campus - Cardiology | Aurora, 80045, United States |
Not yet recruiting | Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension | Cincinnati, 45229, United States |
Not yet recruiting | Cleveland Clinic Children's | Cleveland, 44195, United States |
Not yet recruiting | Emory University Hospital - Children's Healthcare of Atlanta Cardiology | Atlanta, 30329, United States |
Not yet recruiting | Nationwide Children's Hospital - Cardiology | Columbus, 43205, United States |
Not yet recruiting | St. Louis Children's Hospital (SLCH) | Saint Louis, 63110, United States |
Not yet recruiting | UF Health Shands Hospital - Pediatric Cardiology | Gainesville, 32608, United States |
Not yet recruiting | C.S. Mott Children's Hospital - Cardiology | Ann Arbor, 48109, United States |
Not yet recruiting | Medical Center Nora- Heart ?OOD Child Cardiology | Sofia, 1431, Bulgaria |
Not yet recruiting | Children's Mercy Hospital Kansas City - Cardiology | Kansas City, 64108, United States |
Not yet recruiting | Children's Medical Center Dallas - Cardiology | Dallas, 75235, United States |
Not yet recruiting | Riley Hospital For Children - Hematology/Oncology | Indianapolis, 46202, United States |
Not yet recruiting | Nemours Children's Hospital -Delaware | Wilmington, 19803, United States |
Not yet recruiting | Columbia University Irving Medical Center - Pediatric Cardiology | New York, 10032, United States |
Not yet recruiting | Primary Children’s Hospital | Salt Lake City, 84113, United States |
Not yet recruiting | The Children's Hospital at Montefiore - Cardiology | Bronx, 10467, United States |
Not yet recruiting | Children's Hospital of Philadelphia - Cardiology | Philadelphia, 19104, United States |
Not yet recruiting | Oulu University Hospital, Department of Paediatrics and Adolescent Services | Oulu, 90220, Finland |
Not yet recruiting | Texas Children's Hospital - Cardiology | Houston, 77030, United States |
Not yet recruiting | Icahn School of Medicine at Mount Sinai - Pediatric Cardiology | New York, 10029, United States |
Not yet recruiting | Centro Materno infantil do Norte - Pediatric Cardiology | Porto, 4050-651, Portugal |
Not yet recruiting | MUSC Shawn Jenkins Children's Hospital - Cardiology | Charleston, 29401, United States |
Not yet recruiting | UPMC Children's Hospital of Pittsburgh - Cardiology | Pittsburgh, 15224, United States |
Primary Outcome
- Change in NT-proBNP levelsdate_rangeTime Frame:From baseline to Day 90±3
Secondary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)TEAEs will be mapped to Medical Dictionary for Regulatory Activities (MedDRA) termsdate_rangeTime Frame:From the start of study intervention to last study intervention (up to 93 days) + 3 days
- Change in serum potassium levelsdate_rangeTime Frame:From baseline to Day 90±3
- Change in estimated glomerular filtration rate (eGFR)date_rangeTime Frame:From baseline to Day 90±3
- Change in systolic blood pressure (SBP)date_rangeTime Frame:From baseline to Day 90±3
- Change in key echocardiographic parameters of left ventricular systolic function and sizeKey echocardiographic measures will include left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD) and volumes (LVEDV, LVESV), E/e’ ratio, global longitudinal strain (GLS), estimated right ventricular pressure (RVp), and grade of mitral regurgitation (MR)date_rangeTime Frame:From baseline to Day 90±3
- Total number of cardiovascular outcome events, including cardiovascular death, heart transplantation, and clinical worsening of heart failuredate_rangeTime Frame:From baseline to Day 90±3
- Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md)date_rangeTime Frame:Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 90±3
- Area under the curve for finerenone concentration in plasma after multiple doses (AUCτ,md)date_rangeTime Frame:Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 90±3
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2