Actively Recruiting
A Phase 3 Open-Label Extension Study to Evaluate the Safety of Finerenone with Standard Treatment in Children and Young Adults with Heart Failure and Left Ventricular Systolic Dysfunction
Led by Bayer · Updated on 2026-06-05
117
Participants Needed
132
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring a new treatment called finerenone for children and young adults with heart failure and left ventricular systolic dysfunction (LVSD), where the heart's left side is weak and struggles to pump blood. This study aims to evaluate the long-term safety and effectiveness of finerenone, which may help reduce inflammation and scarring in the heart and blood vessels. The study includes newborns, children, and young adults up to 18 years old, including participants from a previous related study called FIORE. Participants will receive finerenone along with their usual heart failure treatments for up to 9 months. The study plans for around 6 visits during this period to monitor health and treatment effects. Newborns under 6 months with LVSD and elevated NT-pro BNP levels are included, and all will continue standard care alongside the study treatment. During the study visits, participants will have their vital signs checked, blood samples taken, physical exams, and heart function assessed with ECG and echocardiography. Feedback about medication and any medical problems will be collected, especially from parents or guardians for younger children. The study team will closely monitor safety by tracking adverse events, potassium levels, blood pressure, and kidney function. After finishing the treatment, participants will have a follow-up health check one month later. Overall, the study lasts about 10 to 11 months, depending on participant group.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants rolling over from the prior finerenone Phase 3 FIORE study without permanent discontinuation before end of treatment.
- Newly enrolled infants under 6 months with left ventricular systolic dysfunction (ejection fraction ≤ 50%) at screening.
- Newly enrolled infants under 6 months with NT-pro BNP levels above 500 mg/L at screening.
- Newly enrolled infants under 6 months with heart failure due to specific causes including congenital heart defects, cardiomyopathies, myocarditis history, neuromuscular or metabolic disorders, ischemic causes, or left ventricular noncompaction.
- Receiving stable standard of care treatment for heart failure for at least 30 days before baseline.
- Newborns and infants under 6 months must weigh at least 3 kg at first visit.
You will not qualify if you...
- Potassium levels above 5.5 mmol/L for participants rolling over from previous study; different potassium thresholds apply based on prior treatment and age.
- Newly enrolled newborns and infants under 6 months with potassium levels 5.3 mmol/L or higher, adjusted for kidney function.
- Severe kidney dysfunction with eGFR below 30 mL/min/1.73m² at screening or previous study end.
- Use of other mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) within 30 days before first visit.
- Need for intravenous vasoactive agents, mechanical ventilation, circulatory support, or uncontrolled arrhythmias within 30 days before treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 270±7 days
Participants receive finerenone treatment along with their standard care for heart failure.
Multiple visits throughout treatment period
Trial Site Locations
Total: 132 locations
1
Children's Hospital Colorado - Anschutz Medical Campus - Cardiology
Aurora, Colorado, United States, 80045
Not Yet Recruiting
2
Nemours Children's Hospital - Delaware - Cardiology
Wilmington, Delaware, United States, 19803
Not Yet Recruiting
3
UF Health Shands Hospital - Pediatric Cardiology
Gainesville, Florida, United States, 32608
Not Yet Recruiting
4
Joe Dimaggio Children's Hospital - Cardiology
Hollywood, Florida, United States, 33021
Not Yet Recruiting
5
Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta
Atlanta, Georgia, United States, 30329
Not Yet Recruiting
6
Riley Hospital For Children - Cardiology
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
7
Boston Children's Hospital - Main Campus - Cardiology
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
8
C.S. Mott Children's Hospital - Cardiology
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
9
Children's Mercy Hospital Kansas City - Cardiology
Kansas City, Missouri, United States, 64108
Not Yet Recruiting
10
Washington University - St. Louis Children's Hospital - Cardiology
St Louis, Missouri, United States, 63110
Not Yet Recruiting
11
Icahn School of Medicine at Mount Sinai - Pediatric Cardiology
New York, New York, United States, 10029
Not Yet Recruiting
12
Columbia University Irving Medical Center - Pediatric Cardiology
New York, New York, United States, 10032
Not Yet Recruiting
13
The Children's Hospital at Montefiore - Cardiology
The Bronx, New York, United States, 10467
Not Yet Recruiting
14
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
15
Cleveland Clinic Children's
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
16
Nationwide Children's Hospital - Cardiology
Columbus, Ohio, United States, 43205
Not Yet Recruiting
17
Children's Hospital of Philadelphia - Cardiology
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
18
UPMC Children's Hospital of Pittsburgh - Cardiology
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
19
MUSC Shawn Jenkins Children's Hospital - Cardiology
North Charleston, South Carolina, United States, 29406
Not Yet Recruiting
20
Children's Medical Center Dallas - Cardiology
Dallas, Texas, United States, 75235
Not Yet Recruiting
21
Texas Children's Hospital - Cardiology
Houston, Texas, United States, 77030
Not Yet Recruiting
22
Eccles Primary Children's Outpatient Services - Cardiology
Salt Lake City, Utah, United States, 84113
Not Yet Recruiting
23
Hospital de Niños Sor María Ludovica
La Plata, Buenos Aires, Argentina, 1900
Not Yet Recruiting
24
Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina
Zárate, Buenos Aires, Argentina, B2800DGH
Not Yet Recruiting
25
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos
Rosario, Santa Fe Province, Argentina, S2000DEJ
Not Yet Recruiting
26
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1199ABB
Not Yet Recruiting
27
Hospital de Pediatría Juan P. Garrahan
Buenos Aires, Argentina, C1249ABN
Not Yet Recruiting
28
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Buenos Aires, Argentina, C1270
Not Yet Recruiting
29
Hospital General de Ninos Ricardo Gutierrez | Cardiology Department
Ciudad Autónoma de Buenos Aire, Argentina, C1425EFD
Not Yet Recruiting
30
Consultorios Médicos Dr. Doreski
Ciudad Autónoma de Buenos Aire, Argentina, C1426ABP
Not Yet Recruiting
31
Sanatorio de la Cañada
Córdoba, Argentina, X5000BSQ
Not Yet Recruiting
32
Centro Cardiovascular Salta (Torzav SRL)
Salta, Argentina, A4406BPF
Not Yet Recruiting
33
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie
Vienna, State of Vienna, Austria, 1090
Not Yet Recruiting
34
Kepler Universitätsklinikum GmbH - Klinik für Kinderkardiologie
Innsbruck, Upper Austria, Austria, 6020
Not Yet Recruiting
35
UZ Leuven - Pediatric Cardiology
Leuven, Flemish Brabant, Belgium, 3000
Not Yet Recruiting
36
Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology
Brussels, Belgium, 1200
Not Yet Recruiting
37
UZ Antwerpen - Pediatric Cardiology
Edegem, Belgium, 2650
Not Yet Recruiting
38
UZ Gent - Pediatric Cardiology
Ghent, Belgium, 9000
Not Yet Recruiting
39
CHC MontLegia - Pediatric Cardiology
Liège, Belgium, 4000
Not Yet Recruiting
40
Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares - EBSERH
Uberlândia, Minas Gerais, Brazil, 38405-325
Withdrawn
41
Hospital Pequeno Principe
Curitiba, Paraná, Brazil, 80250-060
Not Yet Recruiting
42
Centro de Pesquisa Clinica e Populacional Hospitalize
Porto Alegre, Rio Grande do Sul, Brazil, 90810-080
Not Yet Recruiting
43
Fundação Universidade de Caxias do Sul
Marília, São Paulo, Brazil, 95070-560
Not Yet Recruiting
44
Liga Alvaro Bahia Contra a Mortalidade Infantil - Hospital Martagão Gesteira
Salvador, São Paulo, Brazil, 40050050
Not Yet Recruiting
45
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
São Paulo, São Paulo, Brazil, 01227-200
Not Yet Recruiting
46
Instituto Dante Pazzanese de Cardiologia | Divisao de Pesquisa
São Paulo, São Paulo, Brazil, 04012-180
Not Yet Recruiting
47
Campinas Clinical Research Institute (IPECC) | Campinas, Brazil
São Paulo, São Paulo, Brazil, 13060-080
Not Yet Recruiting
48
Santa Casa de Misericórdia de Belo Horizonte
São Paulo, São Paulo, Brazil, 30150-221
Not Yet Recruiting
49
InCor HCFMUSP
São Paulo, São Paulo, Brazil, 54030-000
Not Yet Recruiting
50
University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric Clinic
Plovdiv, Plovdiv Province, Bulgaria, 4000
Not Yet Recruiting
51
National Heart Hospital (NHH) - Dept. Pediatric Cardiology
Sofia, Sofia City Province, Bulgaria, 1309
Not Yet Recruiting
52
Medical Center Nora- Heart ?OOD Child Cardiology
Sofia, Sofia City Province, Bulgaria, 1431
Not Yet Recruiting
53
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
Sofia, Sofia City Province, Bulgaria, 1431
Not Yet Recruiting
54
Stollery Children's Hospital | Cardiology
Edmonton, Alberta, Canada, T6G 2B7
Not Yet Recruiting
55
BC Children's Hospital | Children's Heart Centre
Vancouver, British Columbia, Canada, V6H 3N1
Withdrawn
56
Children's Hospital | Cardiology
London, Ontario, Canada, N6A 5W9
Not Yet Recruiting
57
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada, M5G 1X8
Not Yet Recruiting
58
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal, Quebec, Canada, H3T 1C5
Not Yet Recruiting
59
Royal University Hospital | Cardiology
Saskatoon, Saskatchewan, Canada, S7N 0W8
Not Yet Recruiting
60
Fakultní nemocnice Brno, Detská nemocnice - Pediatrická klinika
Brno, Czechia, 613 00
Not Yet Recruiting
61
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Detské kardiocentrum 2. LF UK a FN Motol
Prague, Czechia, 150 06
Not Yet Recruiting
62
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia
Helsinki, Uusimaa, Finland, 00290
Not Yet Recruiting
63
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene Herzfehler
Giessen, Hesse, Germany, 35385
Not Yet Recruiting
64
Universitätsklinikum Köln - Kinderkardiologie
Cologne, Germany, 50937
Withdrawn
65
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin
Tübingen, Germany, 72076
Not Yet Recruiting
66
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart Disease
Kallithea, Attica, Greece, 17674
Not Yet Recruiting
67
Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics
Athens, Greece, 11527
Not Yet Recruiting
68
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department
Athens, Greece, 11527
Not Yet Recruiting
69
Nosokomeio Paidon I Agia Sofia, Cardiology Department
Athens, Greece, 11527
Not Yet Recruiting
70
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet - Gyermeksziv Kozpont
Budapest, Hungary, 1096
Not Yet Recruiting
71
Rambam Health Corporation
Haifa, Israel, 3109601
Withdrawn
72
Edith Wolfson Medical Center (EWMC)
Holon, Israel, 58100
Not Yet Recruiting
73
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Not Yet Recruiting
74
Dana-Dwek Children's Hospital
Tel Aviv, Israel, 6423906
Not Yet Recruiting
75
Chaim Sheba Medical Center
Tel Litwinsky, Israel, 52621
Not Yet Recruiting
76
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adulto
Bergamo, Italy, 24127
Not Yet Recruiting
77
Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutiva
Bologna, Italy, 40138
Not Yet Recruiting
78
IRCCS Istituto Giannina Gaslini - Cardiologia
Genova, Italy, 16147
Not Yet Recruiting
79
ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica
Milan, Italy, 20162
Not Yet Recruiting
80
Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari
Naples, Italy, 80131
Not Yet Recruiting
81
Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica
Padova, Italy, 35128
Not Yet Recruiting
82
Ospedale Pediatrico Bambino Gesù - Unità Terapie Cardiovascolari Avanzate
Roma, Italy, 00165
Not Yet Recruiting
83
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatrica
Torino, Italy, 10126
Not Yet Recruiting
84
Centro de Investigación Clínica Médica y Farmacológica S.A de C.V
Guadalajara, Jalisco, Mexico, C.P.44690
Not Yet Recruiting
85
Hospital Infantil de México "Dr. Federico Gómez"
Mexico City, Mexico City, Mexico, 6720
Withdrawn
86
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria
Monterrey, Nuevo León, Mexico, C.P. 64460
Not Yet Recruiting
87
Invecordis Sc.
Huixquilucan, State of Mexico, Mexico, 52763
Not Yet Recruiting
88
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, Mexico, C.P. 89440
Not Yet Recruiting
89
Centro de Estudios Clínicos de Querétaro S.C.
Querétaro, Mexico, 76000
Not Yet Recruiting
90
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City, Mexico, 72300
Not Yet Recruiting
91
Instituto Nacional de Cardiología "Ignacio Chávez"
Tlalpan, Mexico, C.P. 14080
Not Yet Recruiting
92
Pomnik Centrum Zdrowia Dziecka - Klinika Kardiologii
Warsaw, Masovian Voivodeship, Poland, 04-730
Withdrawn
93
Górnoslaskie Centrum Zdrowia Dziecka im. sw. Jana Pawla II SPSK Nr 6 Slaskiego UM w Katowicach - Oddzial Kardiologii Dzieciecej
Katowice, Poland, 40-752
Not Yet Recruiting
94
Instytut Centrum Zdrowia Matki Polki w Lodzi - Klinika Kardiologii
Lódz, Poland, 93-338
Withdrawn
95
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Wroclaw, Poland, 51-124
Not Yet Recruiting
96
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia Pediátrica
Coimbra, Portugal, 3004-561
Not Yet Recruiting
97
Hospital Santa Marta | Pediatric Cardiology Department
Lisbon, Portugal, 1169-024
Not Yet Recruiting
98
Hospital de Santa Cruz | Pediatric Cardiology Department
Lisbon, Portugal, 1449-005
Not Yet Recruiting
99
Unidade Local de Saúde de Santo António, E.P.E. - Centro Materno Infantil do Norte - Serviço de Cardiologia Pediátrica
Porto, Portugal, 4050-651
Not Yet Recruiting
100
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Pediatria
Porto, Portugal, 4200-319
Not Yet Recruiting
101
Pusan National University Yangsan Children's Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
Not Yet Recruiting
102
Seoul National University Hospital-Pediatrics Department
Jongno, Seoul, South Korea, 03080
Not Yet Recruiting
103
Severance Hospital, Yonsei University Health System-Pediatrics Department
Seodaemun, South Korea, 03722
Not Yet Recruiting
104
Samsung Medical Center-Pediatrics
Seoul, South Korea, 06351
Not Yet Recruiting
105
Hospital Sant Joan De Deu Barcelona | Cardiologia pediatrica
Esplugues de Llobregat, Barcelona, Spain, 8950
Not Yet Recruiting
106
Hospital Universitari Vall D Hebron | Cardiologia pediatrica
Barcelona, Spain, 08035
Not Yet Recruiting
107
Hospital Universitario Reina Sofia | Cardiologia pediatrica
Córdoba, Spain, 14004
Not Yet Recruiting
108
Hospital Universitario Ramon Y Cajal | Cardiologia pediatrica
Madrid, Spain, 28034
Withdrawn
109
Hospital Universitario 12 De Octubre | Cardiologia pediatrica
Madrid, Spain, 28041
Not Yet Recruiting
110
Hospital Universitario La Paz | Cardiologia pediatrica
Madrid, Spain, 28046
Not Yet Recruiting
111
Hospital Universitario Regional De Malaga | Cardiologia pediatrica
Málaga, Spain, 29010
Not Yet Recruiting
112
Hospital Universitario Virgen Del Rocio S.L. | Cardiologia pediatrica
Seville, Spain, 41013
Not Yet Recruiting
113
Skånes Universitetssjukhus - Lund - Barnhjärtcentrum
Lund, Skåne County, Sweden, 222 41
Not Yet Recruiting
114
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Guishan, Taoyuan, Taiwan, 83301
Not Yet Recruiting
115
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813414
Not Yet Recruiting
116
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
117
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Not Yet Recruiting
118
National Taiwan University Hospital
Taipei, Taiwan, 100
Not Yet Recruiting
119
MacKay Children's hospital
Taipei, Taiwan, 104217
Not Yet Recruiting
120
Cukurova Universitesi Tip Fakultesi Hastanesi
Adana, Turkey (Türkiye), 1330
Not Yet Recruiting
121
Hacettepe Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye), 06230
Not Yet Recruiting
122
Ankara Bilkent Sehir Hastanesi
Bilkent Ankara, Turkey (Türkiye), 6800
Not Yet Recruiting
123
Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji
Istanbul, Turkey (Türkiye), 34899
Not Yet Recruiting
124
Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.
Istanbul, Turkey (Türkiye), TBC
Not Yet Recruiting
125
Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast
Izmir, Turkey (Türkiye), 35210
Not Yet Recruiting
126
University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility
Leicester, Leicestershire, United Kingdom, LE1 5WW
Not Yet Recruiting
127
Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility
Liverpool, Merseyside, United Kingdom, L122AP
Not Yet Recruiting
128
Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Not Yet Recruiting
129
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
Glasgow, Scotland, United Kingdom, G51 4TF
Not Yet Recruiting
130
Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Not Yet Recruiting
131
Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Not Yet Recruiting
132
University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility
Bristol, United Kingdom, BS2 8AE
Not Yet Recruiting
Research Team
B
Bayer Clinical Trials Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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