Not Yet Recruiting

Left ventricular systolic dysfunction, Heart failure (Pediatric)

Bayer Identifier:

21467

ClinicalTrials.gov Identifier:

NCT07192952

EudraCT Number:

Not Available

EU CT Number:

2024-519830-22-00

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

NaN - 18 Years

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.

Trial summary

Enrollment Goal

117

Trial Dates

January 2026 - December 2030

Phase

Phase 3

Could I Receive a placebo

Products

Finerenone (BAY94-8862)

Accepts Healthy Volunteer

Where 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	ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica	Milan, 20162, 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	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	Lisboa, 1449-005, 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-Pediatrics	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 Health System-Pediatrics Department	Seodaemun, 03722, Korea,_republic_of
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 Reina Sofia - Nefrologia	Cordoba, 14004, Spain
Not yet recruiting	Hospital Universitario Virgen Del Rocio S.L. - Cardiologia	Sevilla, 41013, Spain
Not yet recruiting	Hospital Universitario Ramon Y Cajal - Oncologia Radioterapica	Madrid, 28034, Spain
Not yet recruiting	Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch	Guishan, 83301, 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	Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.	Istanbul, TBC, Turkey
Not yet recruiting	Ankara Bilkent Sehir Hastanesi	Bilkent ankara, 6800, Turkey
Not yet recruiting	Hacettepe Universitesi Tip Fakultesi	Ankara, 6100, Turkey
Not yet recruiting	National Taiwan University Hospital	Taipei, 100, 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	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	Wojewódzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo-Rozwojowy Oddzial Kardiologii Dzieciecej	Wroclaw, 51-124, Poland
Not yet recruiting	Hospital Universitari Vall d´Hebron_ Nefrologia	Barcelona, 08035, Spain
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	Centro Cardiovascular Salta (Torzav SRL)	Salta, A4406BPF, Argentina
Not yet recruiting	Hospital General de Ninos Ricardo Gutierrez \| Pediatric Nephrology Department	Ciudad Autónoma de Buenos Aire, 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	Buenos Aires, C1270, 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	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	Centro de Investigación Clínica Médica y Farmacológica S.A de C.V	Guadalajara, C.P.44690, Mexico
Not yet recruiting	Hospital Infantil de México "Dr. Federico Gómez"	Ciudad de Mexico, 6720, Mexico
Not yet recruiting	Instituto Nacional de Cardiología "Ignacio Chávez"	Tlalpan, C.P. 14080, Mexico
Not yet recruiting	National Heart Hospital (NHH) - Dept. Pediatric Cardiology	Sofia, 1309, Bulgaria
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	Cukurova Universitesi Tip Fakultesi Hastanesi	Adana, 1330, Turkey
Not yet recruiting	Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji	Istanbul, 34899, Turkey
Not yet recruiting	Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast	Izmir, 35210, Turkey
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	BC Children’s Hospital - Children's Heart Centre	Vancouver, V6H 3V4, Canada
Not yet recruiting	University of Saskatchewan, Royal University Hospital	Saskatoon, S7N 0W8, Canada
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	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	Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics	Athens, 11527, Greece
Not yet recruiting	Medical Center Nora- Heart ?OOD Child Cardiology	Sofia, 1431, Bulgaria
Not yet recruiting	Fakultní nemocnice v Motole - Detské kardiocentrum 2. LF UK a FN Motol	Praha 5, 150 06, Czech Republic
Not yet recruiting	Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinika	Brno, 613 00, Czech Republic
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	Children's Medical Center Dallas - Cardiology	Dallas, 75235, United States
Not yet recruiting	Children's Mercy Hospital Kansas City - Cardiology	Kansas City, 64108, United States
Not yet recruiting	Icahn School of Medicine at Mount Sinai - Pediatric Cardiology	New York, 10029, United States
Not yet recruiting	Nationwide Children's Hospital - Cardiology	Columbus, 43205, 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	St. Louis Children's Hospital (SLCH)	Saint Louis, 63110, 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	Atlanta, 30329, United States
Not yet recruiting	Riley Hospital For Children - Cardiology	Indianapolis, 46202, United States
Not yet recruiting	Joe Dimaggio Children's Hospital - Cardiology	Hollywood, 33021, United States
Not yet recruiting	Texas Children's Hospital - Cardiology	Houston, 77030, 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	UF Health Shands Hospital - Pediatric Cardiology	Gainesville, 32608, United States
Not yet recruiting	Centro Materno infantil do Norte - Pediatric Cardiology	Porto, 4050-651, Portugal
Not yet recruiting	C.S. Mott Children's Hospital - Cardiology	Ann Arbor, 48109, United States
Not yet recruiting	Chaim Sheba Medical Center	Tel Hashomer, 52621, Israel
Not yet recruiting	Edith Wolfson Medical Center (EWMC)	Holon, 58100, Israel
Not yet recruiting	Rambam Health Corporation	Haifa, 3109601, Israel
Not yet recruiting	Shaare Zedek Medical Center	Jerusalem, 9103102, Israel
Not yet recruiting	Dana-Dwek Children’s Hospital	Tel-Aviv, 6423906, Israel
Not yet recruiting	HUS Uusi lastensairaala - Lasten kardiologian vastaanotot	Helsinki, 00290, Finland
Not yet recruiting	UPMC Children's Hospital of Pittsburgh - Cardiology	Pittsburgh, 15224, United States
Not yet recruiting	Boston Children's Hospital - Main Campus - Cardiology	Boston, 02215, United States
Not yet recruiting	MUSC Shawn Jenkins Children's Hospital - Cardiology	North Charleston, 29406, United States

Primary Outcome

Number of participants with treatment-emergent adverse events (TEAEs)
TEAEs will be mapped to Medical Dictionary for Regulatory Activities (MedDRA) terms.
Time Frame:
From the start of study intervention to last study intervention (up to 277 days) + 3 days
Change in serum potassium levels
Time Frame:
From baseline to Day 270±7
Change in systolic blood pressure (SBP)
Time Frame:
From baseline to Day 270±7
Change in estimated glomerular filtration rate (eGFR)
Time Frame:
From baseline to Day 270±7

Secondary Outcome

Change in NT-proBNP levels
Time Frame:
From baseline to Day 270±7
Change in left ventricular systolic function
Change measured by echocardiogram (%) from baseline to Day 270±7
Time Frame:
From baseline to Day 270±7
Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md)
Time Frame:
Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to Day 270±7
Area under the curve for finerenone concentration in plasma after multiple doses (AUCτ,md)
Time Frame:
Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to Day 270±7
Taste and Texture Questionnaire of the pediatric formulation
For newborns and infants <6 months of age, the taste and texture of the pediatric formulation will be evaluated using the Taste and Texture Questionnaire, completed by the caregiver, or health care professional. Results for the Taste and Texture Questionnaire from newborns and infants <6 months of age who receive the pediatric formulation will be summarized descriptively.
Time Frame:
On Day 30±3 and Day 270±7

Trial design

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)

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

N/A

Assignment

Single Group Assignment

Trial Arms

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.