pause_circle_filledNot Yet Recruiting

Left ventricular systolic dysfunction, Heart failure (Pediatric)

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.

Key Participants Requirements

Sex

All

Age

6 - 17 Years

Trial summary

Enrollment Goal
111
Trial Dates
September 2025 - December 2029
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Azienda Ospedale-Università di Padova - UOC Cardiologia PediatricaPadova, 35128, Italy
Not yet recruiting
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatricaTorino, 10126, Italy
Not yet recruiting
Ospedale Pediatrico Bambino Gesù - Unità Terapie Cardiovascolari AvanzateRoma, 00165, Italy
Not yet recruiting
IRCCS Istituto Giannina Gaslini - CardiologiaGenova, 16147, Italy
Not yet recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adultoBergamo, 24127, Italy
Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatricaMilan, 20162, Italy
Not yet recruiting
Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutivaBologna, 40138, Italy
Not yet recruiting
Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche CardiovascolariNaples, 80131, Italy
Not yet recruiting
Hospital Santa Marta | Pediatric Cardiology DepartmentLisbon, 1169-024, Portugal
Not yet recruiting
Hospital de Santa Cruz | Pediatric Cardiology DepartmentCarnaxide, 2790-134, Portugal
Not yet recruiting
ULS São João - Pediatric DepartmentPorto, 4200-319, Portugal
Not yet recruiting
Department of Cardiology - Research UnitCoimbra, 3004-561, Portugal
Not yet recruiting
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet - Gyermeksziv KozpontBudapest, 1096, Hungary
Not yet recruiting
Nosokomeio Paidon I Agia Sofia, Cardiology DepartmentAthens, 11527, Greece
Not yet recruiting
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology DepartmentAthens, 11527, Greece
Not yet recruiting
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart DiseaseKalithea, 17674, Greece
Not yet recruiting
Pusan National University Yangsan HospitalYangsan-si, 50612, Korea,_republic_of
Not yet recruiting
Samsung Medical Center - Oncology DepartmentSeoul, 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 MotolPraha 5, 150 06, Czech Republic
Not yet recruiting
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische KardiologieVienna, 1090, Austria
Not yet recruiting
Kepler Universitätsklinikum GmbH - Klinik für KinderkardiologieLinz, 4020, Austria
Not yet recruiting
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene HerzfehlerGiessen, 35385, Germany
Not yet recruiting
Universitätsklinikum Köln - KinderkardiologieKöln, 50937, Germany
Not yet recruiting
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, IntensivmedizinTübingen, 72076, Germany
Not yet recruiting
Hospital Universitario Regional De Malaga - Cardiologia pediatricaMalaga, 29010, Spain
Not yet recruiting
Hospital de Sant Joan de DéuEsplugues de LLobregat, 8950, Spain
Not yet recruiting
Hospital Universitario 12 de OctubreMadrid, 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 pediatricaMadrid, 28034, Spain
Not yet recruiting
Hospital Universitario Reina Sofia - Cardiologia pediatricaCórdoba, 14004, Spain
Not yet recruiting
Hospital Universitario Virgen Del Rocio S.L. - Cardiologia pediatricaSevilla, 41013, Spain
Not yet recruiting
Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinikaBrno, 613 00, Czech Republic
Not yet recruiting
Chaim Sheba Medical CenterTel Hashomer, 52621, Israel
Not yet recruiting
Shaare Zedek Medical CenterJerusalem, 9103102, Israel
Not yet recruiting
Chang Gung Memorial Hospital KaohsiungKaohsiung, 833, Taiwan
Not yet recruiting
MacKay Children's hospitalTaipei, 104217, Taiwan
Not yet recruiting
National Cheng Kung University HospitalTainan, 704, Taiwan
Not yet recruiting
National Taiwan University HospitalTaipei, 100225, Taiwan
Not yet recruiting
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Not yet recruiting
Kaohsiung Veterans General HospitalKaohsiung City, 813414, Taiwan
Not yet recruiting
Joe Dimaggio Children's Hospital - CardiologyHollywood, 33021, United States
Not yet recruiting
Edith Wolfson Medical Center (EWMC)Holon, 58100, Israel
Not yet recruiting
Rambam Health CorporationHaifa, 3109601????, Israel
Not yet recruiting
Dana-Dwek Children’s HospitalTel-Aviv, 6423906, Israel
Not yet recruiting
Instytut Centrum Zdrowia Matki Polki w Lodzi - Klinika KardiologiiLódz, 93-338, Poland
Not yet recruiting
Górnoslaskie Centrum Zdrowia Dziecka im. sw. Jana Pawla II SPSK Nr 6 Slaskiego UM w Katowicach - Oddzial Kardiologii DzieciecejKatowice, 40-752, Poland
Not yet recruiting
Pomnik Centrum Zdrowia Dziecka - Klinika KardiologiiWarszawa, 04-730, Poland
Not yet recruiting
Wojewodzki Szpital Specjalistyczny we WroclawiuWroclaw, 51-124, Poland
Not yet recruiting
London Health Sciences Centre - Children's HospitalLondon, N6A 5W9, Canada
Not yet recruiting
The Hospital for Sick Children (SickKids)Toronto, M5G 1X8, Canada
Not yet recruiting
CHU Sainte-JustineMontreal, H3T 1C5, Canada
Not yet recruiting
Ankara Bilkent Sehir HastanesiBilkent ankara, 6800, Turkey
Not yet recruiting
Hacettepe Universitesi Tip FakultesiAnkara, 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 KardiyolojiIstanbul, 34899, Turkey
Not yet recruiting
BC Children’s Hospital - Children's Heart CentreVancouver, V6H 3V4, Canada
Not yet recruiting
Hospital Universitari Vall d´Hebron_ NefrologiaBarcelona, 08035, Spain
Not yet recruiting
CHC MontLegia - Pediatric CardiologyLiège, 4000, Belgium
Not yet recruiting
Cliniques Universitaires St-Luc (UCL) - Pediatric CardiologyBrussels, 1200, Belgium
Not yet recruiting
UZ Gent - Pediatric CardiologyGent, 9000, Belgium
Not yet recruiting
UZ Leuven - Pediatric CardiologyLeuven, 3000, Belgium
Not yet recruiting
UZ Antwerpen - Pediatric CardiologyEdegem, 2650, Belgium
Not yet recruiting
National Heart Hospital (NHH) - Dept. Pediatric CardiologySofia, 1309, Bulgaria
Not yet recruiting
Fundação Universidade de Caxias do SulCaxias do Sul, 95070-560, Brazil
Not yet recruiting
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde InfantilSao Paulo, 01227-200, Brazil
Not yet recruiting
Hospital Pequeno PrincipeCuritiba, 80250-060, Brazil
Not yet recruiting
InCor HCFMUSPSão Paulo, 5403000, Brazil
Not yet recruiting
Instituto Dante Pazzanese de Cardiologia | Divisao de PesquisaSão Paulo, 04012-180, Brazil
Not yet recruiting
Campinas Clinical Research Institute (IPECC) | Campinas, BrazilCampinas, 13060-080, Brazil
Not yet recruiting
Santa Casa de Misericórdia de Belo HorizonteBelo Horizonte, 30150-221, Brazil
Not yet recruiting
Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares – EBSERHUberlandia, 38405-325, Brazil
Not yet recruiting
IESG - Instituto de Ensino da Saude e GestaoSalvador, 40050-050, Brazil
Not yet recruiting
Centro de Pesquisa Clinica e Populacional HospitalizePorto Alegre, 90810-080, Brazil
Not yet recruiting
Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric CardiologyBelfast, BT12 6BE, United Kingdom
Not yet recruiting
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research FacilityGlasgow, G51 4TF, United Kingdom
Not yet recruiting
Leeds Teaching Hospitals NHS Trust | Leeds Children’s Hospital - Children's Research FacilityLeeds, LS1 3EX, United Kingdom
Not yet recruiting
Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart UnitNewcastle upon Tyne, NE7 7DN, United Kingdom
Not yet recruiting
University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research FacilityBristol, BS2 8AE, United Kingdom
Not yet recruiting
University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research FacilityLeicester, LE1 5WW, United Kingdom
Not yet recruiting
Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research FacilityLiverpool, L122AP, United Kingdom
Not yet recruiting
University of Saskatchewan, Royal University HospitalSaskatoon, S7N 0W8, Canada
Not yet recruiting
Centro Cardiovascular Salta (Torzav SRL)Salta, A4406BPF, Argentina
Not yet recruiting
Cukurova Universitesi Tip Fakultesi HastanesiAdana, 1330, Turkey
Not yet recruiting
Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology DepartmentBuenos Aires, C1425EFD, Argentina
Not yet recruiting
Hospital de Pediatría Juan P. GarrahanBuenos Aires, C1249ABN, Argentina
Not yet recruiting
Hospital General de Ninos Pedro de Elizalde | Nephrology DepartmentCiudad Autonoma de Buenos Aire, C1270AAN, Argentina
Not yet recruiting
Sanatorio de la CañadaCordoba, X5000BSQ, Argentina
Not yet recruiting
Hospital Italiano de Buenos AiresBuenos Aires, C1199ABB, Argentina
Not yet recruiting
Instituto De Investigaciones Clinicas Zarate | Zarate, ArgentinaZárate, B2800DGH, Argentina
Not yet recruiting
Hospital de Niños Sor María LudovicaLa Plata, 1900, Argentina
Not yet recruiting
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios ClinicosRosario, S2000DEJ, Argentina
Not yet recruiting
Consultorios Médicos Dr. DoreskiCiudad Autónoma de Buenos Aire, C1426ABP, Argentina
Not yet recruiting
Izmir Dr. Behcet Uz Cocuk Hastaliklari HastIzmir, 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 CardiovascularesCd. Madero, C.P. 89440, Mexico
Not yet recruiting
CINVEC MedicaGuadalajara, 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, SofiaSofia, 1431, Bulgaria
Not yet recruiting
University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric ClinicPlovdiv, 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)-LomasHuixquilucan, 52763, Mexico
Not yet recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-PediatriaMonterrey, C.P. 64460, Mexico
Not yet recruiting
Skånes Universitetssjukhus Lund - BarnhjärtcentrumLund, 222 41, Sweden
Not yet recruiting
HUS Uusi lastensairaala - Lasten kardiologian vastaanototHelsinki, 00290, Finland
Not yet recruiting
Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of PediatricsAthens, 11527, Greece
Not yet recruiting
Boston Children's Hospital - Main Campus - CardiologyBoston, 02215, United States
Not yet recruiting
Children's Hospital Colorado - Anschutz Medical Campus - CardiologyAurora, 80045, United States
Not yet recruiting
Cincinnati Children's Hospital Medical Center | Division of Nephrology and HypertensionCincinnati, 45229, United States
Not yet recruiting
Cleveland Clinic Children'sCleveland, 44195, United States
Not yet recruiting
Emory University Hospital - Children's Healthcare of Atlanta CardiologyAtlanta, 30329, United States
Not yet recruiting
Nationwide Children's Hospital - CardiologyColumbus, 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 CardiologyGainesville, 32608, United States
Not yet recruiting
C.S. Mott Children's Hospital - CardiologyAnn Arbor, 48109, United States
Not yet recruiting
Medical Center Nora- Heart ?OOD Child CardiologySofia, 1431, Bulgaria
Not yet recruiting
Children's Mercy Hospital Kansas City - CardiologyKansas City, 64108, United States
Not yet recruiting
Children's Medical Center Dallas - CardiologyDallas, 75235, United States
Not yet recruiting
Riley Hospital For Children - Hematology/OncologyIndianapolis, 46202, United States
Not yet recruiting
Nemours Children's Hospital -DelawareWilmington, 19803, United States
Not yet recruiting
Columbia University Irving Medical Center - Pediatric CardiologyNew York, 10032, United States
Not yet recruiting
Primary Children’s HospitalSalt Lake City, 84113, United States
Not yet recruiting
The Children's Hospital at Montefiore - CardiologyBronx, 10467, United States
Not yet recruiting
Children's Hospital of Philadelphia - CardiologyPhiladelphia, 19104, United States
Not yet recruiting
Oulu University Hospital, Department of Paediatrics and Adolescent ServicesOulu, 90220, Finland
Not yet recruiting
Texas Children's Hospital - CardiologyHouston, 77030, United States
Not yet recruiting
Icahn School of Medicine at Mount Sinai - Pediatric CardiologyNew York, 10029, United States
Not yet recruiting
Centro Materno infantil do Norte - Pediatric CardiologyPorto, 4050-651, Portugal
Not yet recruiting
MUSC Shawn Jenkins Children's Hospital - CardiologyCharleston, 29401, United States
Not yet recruiting
UPMC Children's Hospital of Pittsburgh - CardiologyPittsburgh, 15224, United States

Primary Outcome

  • Change in NT-proBNP levels
    date_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) terms
    date_rangeTime Frame:
    From the start of study intervention to last study intervention (up to 93 days) + 3 days
  • Change in serum potassium levels
    date_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 size
    Key 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 failure
    date_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

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2