Left Ventricular Systolic DysfunctionPhase 3FIORELLONCT07192952

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

A Phase 3 study testing Finerenone (Kerendia, BAY94-8862) in people with Left Ventricular Systolic Dysfunction and Heart Failure (Pediatric), run by Bayer at 132 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages Up to 18 years
Conditions the study is for: Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
What is being tested?: Finerenone (Kerendia, BAY94-8862)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 132 sitesin 23 countries
Study dates: 1 Jun 2026to 30 Dec 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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 ng/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.

Who cannot join

For participants rolling over from randomized controlled trial (RCT): To roll-over to FIORELLO, all participants: Potassium (K+) >5.5 mmol/L based on local laboratory results. 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 based on local laboratory results at FIORELLO 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 locations and contacts

132 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

Bayer Clinical Trials Contact contact

0018888422937

clinical-trials-contact@bayer.com

Country

City, postcode or hospital

Sites recruiting now only

132 sites in 23 countries

United States22 sites, 22 recruiting

C.S. Mott Children's Hospital - Cardiology
Ann Arbor, Michigan, 48109
Not yet recruiting
Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta
Atlanta, Georgia, 30329
Not yet recruiting
Children's Hospital Colorado - Anschutz Medical Campus - Cardiology
Aurora, Colorado, 80045
Not yet recruiting
Boston Children's Hospital - Main Campus - Cardiology
Boston, Massachusetts, 02215
Not yet recruiting
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Cincinnati, Ohio, 45229
Not yet recruiting
Cleveland Clinic Children's
Cleveland, Ohio, 44195
Not yet recruiting
Nationwide Children's Hospital - Cardiology
Columbus, Ohio, 43205
Not yet recruiting
Children's Medical Center Dallas - Cardiology
Dallas, Texas, 75235
Not yet recruiting
UF Health Shands Hospital - Pediatric Cardiology
Gainesville, Florida, 32608
Not yet recruiting
Joe Dimaggio Children's Hospital - Cardiology
Hollywood, Florida, 33021
Not yet recruiting
Texas Children's Hospital - Cardiology
Houston, Texas, 77030
Not yet recruiting
Riley Hospital For Children - Cardiology
Indianapolis, Indiana, 46202
Not yet recruiting
Children's Mercy Hospital Kansas City - Cardiology
Kansas City, Missouri, 64108
Not yet recruiting
Icahn School of Medicine at Mount Sinai - Pediatric Cardiology
New York, New York, 10029
Not yet recruiting
Columbia University Irving Medical Center - Pediatric Cardiology
New York, New York, 10032
Not yet recruiting
MUSC Shawn Jenkins Children's Hospital - Cardiology
North Charleston, South Carolina, 29406
Not yet recruiting
Children's Hospital of Philadelphia - Cardiology
Philadelphia, Pennsylvania, 19104
Not yet recruiting
UPMC Children's Hospital of Pittsburgh - Cardiology
Pittsburgh, Pennsylvania, 15224
Not yet recruiting
Eccles Primary Children's Outpatient Services - Cardiology
Salt Lake City, Utah, 84113
Not yet recruiting
Washington University - St. Louis Children's Hospital - Cardiology
St Louis, Missouri, 63110
Not yet recruiting
The Children's Hospital at Montefiore - Cardiology
The Bronx, New York, 10467
Not yet recruiting
Nemours Children's Hospital - Delaware - Cardiology
Wilmington, Delaware, 19803
Not yet recruiting

Other trials in United States

Argentina10 sites, 10 recruiting

Hospital General de Ninos Ricardo Gutierrez | Cardiology Department
Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), C1425FED
Not yet recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
Not yet recruiting
Hospital de Pediatría Juan P. Garrahan
Buenos Aires, C1249ABN
Not yet recruiting
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Buenos Aires, C1270
Not yet recruiting
Consultorios Médicos Dr. Doreski
Buenos Aires, C1426ABP
Not yet recruiting
Sanatorio de la Cañada
Córdoba, X5000BSQ
Not yet recruiting
Hospital de Niños Sor María Ludovica
La Plata, Buenos Aires, 1900
Not yet recruiting
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ
Not yet recruiting
Centro Cardiovascular Salta (Torzav SRL)
Salta, A4406BPF
Not yet recruiting
Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina
Zárate, Buenos Aires, B2800DGH
Not yet recruiting

Other trials in Argentina

Brazil10 sites, 9 recruiting

Hospital Pequeno Principe
Curitiba, Paraná, 80250-060
Recruiting
Fundação Universidade de Caxias do Sul
Marília, São Paulo, 95070-560
Not yet recruiting
Centro de Pesquisa Clinica e Populacional Hospitalize
Porto Alegre, Rio Grande do Sul, 90810-080
Not yet recruiting
Liga Alvaro Bahia Contra a Mortalidade Infantil - Hospital Martagão Gesteira
Salvador, Estado de Bahia, 40050050
Not yet recruiting
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
São Paulo, 01227-200
Not yet recruiting
Instituto Dante Pazzanese de Cardiologia | Divisao de Pesquisa
São Paulo, 04012-180
Not yet recruiting
Campinas Clinical Research Institute (IPECC) | Campinas, Brazil
São Paulo, 13060-080
Not yet recruiting
Santa Casa de Misericórdia de Belo Horizonte
São Paulo, 30150-221
Not yet recruiting
InCor HCFMUSP
São Paulo, 54030-000
Not yet recruiting
Hospital de Clínicas da Universidade Federal de Uberlândia Empresa Brasileira de Serviços Hospitalares - EBSERH
Uberlândia, Minas Gerais, 38405-325
Withdrawn

Other trials in Brazil

Italy8 sites, 8 recruiting

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adulto
Bergamo, 24127
Not yet recruiting
Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico Sant'Orsola-Cardiologia pediatrica ed dell'età evolutiva
Bologna, 40138
Not yet recruiting
IRCCS Istituto Giannina Gaslini - Cardiologia
Genoa, Liguria, 16147
Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica
Milan, 20162
Not yet recruiting
Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari
Naples, 80131
Not yet recruiting
Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica
Padova, Veneto, 35128
Not yet recruiting
Ospedale Pediatrico Bambino Gesù - Unità Terapie Cardiovascolari Avanzate
Rome, Lazio, 00165
Not yet recruiting
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatrica
Turin, Piedmont, 10126
Not yet recruiting

Other trials in Italy

Mexico8 sites, 7 recruiting

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, 89440
Not yet recruiting
Centro de Investigación Clínica Médica y Farmacológica S.A de C.V
Guadalajara, Jalisco, 44690
Not yet recruiting
Invecordis Sc.
Huixquilucan, State of Mexico, 52763
Not yet recruiting
Hospital Infantil de México "Dr. Federico Gómez"
México D.F., Mexico City, 6720
Withdrawn
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria
Monterrey, Nuevo León, 64460
Not yet recruiting
Centro de Estudios Clínicos de Querétaro S.C.
Querétaro, 76000
Not yet recruiting
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City, 72300
Not yet recruiting
Instituto Nacional de Cardiología "Ignacio Chávez"
Tlalpan, Mexico City, 14080
Not yet recruiting

Other trials in Mexico

Spain8 sites, 7 recruiting

Hospital Sant Joan De Deu Barcelona | Cardiologia pediatrica
Barcelona, 08035
Not yet recruiting
Hospital Universitari Vall D Hebron | Cardiologia pediatrica
Barcelona, 08035
Not yet recruiting
Hospital Universitario Reina Sofia | Cardiologia pediatrica
Córdoba, 14004
Not yet recruiting
Hospital Universitario 12 De Octubre | Cardiologia pediatrica
Madrid, Madrid, 28041
Not yet recruiting
Hospital Universitario La Paz | Cardiologia pediatrica
Madrid, Madrid, 28041
Recruiting
Hospital Universitario Ramon Y Cajal | Cardiologia pediatrica
Madrid, 28034
Withdrawn
Hospital Universitario Regional De Malaga | Cardiologia pediatrica
Málaga, 29010
Not yet recruiting
Hospital Universitario Virgen Del Rocio S.L. | Cardiologia pediatrica
Seville, 41013
Not yet recruiting

Other trials in Spain

United Kingdom7 sites, 7 recruiting

Royal Belfast Hospital for Sick Children | Paediatric Cardiology
Belfast, Northern Ireland, BT12 6BE
Not yet recruiting
Bristol Royal Hospital for Children | Clinical Research Facility
Bristol, BS2 8AE
Not yet recruiting
Royal Hospital for Children | Glasgow Clinical Research Facility
Glasgow, Scotland, G51 4TF
Not yet recruiting
Leeds Children's Hospital | Children's Research Facility
Leeds, West Yorkshire, LS1 3EX
Not yet recruiting
Leicester Children's Hospital | Children's Research Facility
Leicester, Leicestershire, LE1 5WW
Not yet recruiting
Alder Hey Children's Hospital | Clinical Research Facility
Liverpool, Merseyside, L122AP
Recruiting
Freeman Hospital | Children's Heart Unit
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Not yet recruiting

Other trials in United Kingdom

Canada6 sites, 5 recruiting

Stollery Children's Hospital | Cardiology
Edmonton, Alberta, T6G 2B7
Not yet recruiting
Children's Hospital | Cardiology
London, Ontario, N6A 5W9
Not yet recruiting
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal, Quebec, H3T 1C5
Not yet recruiting
Royal University Hospital | Cardiology
Saskatoon, Saskatchewan, S7N 0W8
Not yet recruiting
The Hospital for Sick Children (SickKids) | Cardiology
Toronto, Ontario, M5G 1X8
Not yet recruiting
BC Children's Hospital | Children's Heart Centre
Vancouver, British Columbia, V6H 3N1
Withdrawn

Other trials in Canada

Taiwan6 sites, 6 recruiting

Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Guishan, Taoyuan, 83301
Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 813414
Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Recruiting
National Cheng Kung University Hospital
Tainan, 704
Not yet recruiting
National Taiwan University Hospital
Taipei, 100
Not yet recruiting
MacKay Children's hospital
Taipei, 104217
Recruiting

Other trials in Taiwan

Turkey (Türkiye)6 sites, 6 recruiting

Cukurova Universitesi Tip Fakultesi Hastanesi
Adana, 1330
Recruiting
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230
Not yet recruiting
Ankara Bilkent Sehir Hastanesi
Bilkent Ankara, Aksaray, 6800
Recruiting
Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.
Istanbul, 34303
Not yet recruiting
Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji
Istanbul, 34899
Not yet recruiting
İzmir Dr. Behcet Uz Cocuk Hastaliklari Hast
Izmir, 35210
Not yet recruiting

Other trials in Turkey (Türkiye)

Belgium5 sites, 5 recruiting

Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology
Brussels, Brussels Capital, 1200
Recruiting
UZ Antwerpen - Pediatric Cardiology
Edegem, Antwerp, 2650
Not yet recruiting
UZ Gent - Pediatric Cardiology
Ghent, East Flanders, 9000
Not yet recruiting
UZ Leuven - Pediatric Cardiology
Leuven, Flemish Brabant, 3000
Not yet recruiting
CHC MontLegia - Pediatric Cardiology
Liège, 4000
Not yet recruiting

Other trials in Belgium

Poland5 sites, 3 recruiting

Uniwersyteckie Centrum Kliniczne - Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca
Gdansk, Pomeranian Voivodeship, 80-957
Not yet recruiting
Górnośląskie Centrum Zdrowia Dziecka im. św. Jana Pawła II SPSK Nr 6 Śląskiego UM w Katowicach - Oddział Kardiologii Dziecięcej
Katowice, Silesian Voivodeship, 40-752
Not yet recruiting
Instytut Centrum Zdrowia Matki Polki w Łodzi - Klinika Kardiologii
Lodz, Łódź Voivodeship, 93-338
Withdrawn
Pomnik Centrum Zdrowia Dziecka - Klinika Kardiologii
Warsaw, Masovian Voivodeship, 04-730
Withdrawn
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-556
Not yet recruiting

Other trials in Poland

Portugal5 sites, 5 recruiting

Hospital de Santa Cruz | Pediatric Cardiology Department
Carnaxide, Oeiras, Lisboa, 2790-134
Not yet recruiting
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia Pediátrica
Coimbra, Beira Litoral, 3000-075
Not yet recruiting
Hospital Santa Marta | Pediatric Cardiology Department
Lisbon, 1169-024
Not yet recruiting
Unidade Local de Saúde de Santo António, E.P.E. - Centro Materno Infantil do Norte - Serviço de Cardiologia Pediátrica
Porto, 4050-651
Not yet recruiting
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Pediatria
Porto, 4200-319
Not yet recruiting

Other trials in Portugal

Bulgaria4 sites, 4 recruiting

University Multiprofile Hospital for Active Treatment 'Sveti Georgi' EAD, Plovdiv Pediatric Clinic
Plovdiv, Plovdiv Province, 4000
Not yet recruiting
National Heart Hospital (NHH) - Dept. Pediatric Cardiology
Sofia, Sofia City Province, 1309
Not yet recruiting
Medical Center Nora- Heart ЕOOD Child Cardiology
Sofia, Sofia City Province, 1431
Recruiting
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
Sofia, Sofia City Province, 1431
Not yet recruiting

Other trials in Bulgaria

Greece4 sites, 4 recruiting

Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics
Athens, 11527
Not yet recruiting
Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department
Athens, 11527
Not yet recruiting
Nosokomeio Paidon I Agia Sofia, Cardiology Department
Athens, 11527
Recruiting
Onassis Cardiac Surgery Center, Department of Pediatric Cardiology and Adult Congenital Heart Disease
Kallithea, Attica, 17674
Not yet recruiting

Other trials in Greece

Israel4 sites, 4 recruiting

Edith Wolfson Medical Center (EWMC)
Holon, Tel Aviv, 58100
Not yet recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
Not yet recruiting
Dana-Dwek Children's Hospital
Tel Aviv, 6423906
Not yet recruiting
Chaim Sheba Medical Center
Tel HaShomer, Tel Aviv, 52621
Not yet recruiting

Other trials in Israel

South Korea4 sites, 4 recruiting

Seoul National University Hospital | Pediatric Cardiology
Seoul, 03080
Not yet recruiting
Severance Hospital | Pediatric Cardiology
Seoul, 03722
Not yet recruiting
Samsung Medical Center | Pediatric Cardiology
Seoul, 06351
Recruiting
Pusan National University Children's Hospital | Pediatric Cardiology
Yangsan, Gyeongsangnam-do, 50612
Not yet recruiting

Other trials in South Korea

Germany3 sites, 1 recruiting

Universitätsklinikum Köln - Kinderkardiologie
Cologne, North Rhine-Westphalia, 50937
Withdrawn
Universitaetsklinikum Giessen und Marburg GmbH - Kinderherzzentrum und Zentrum für angeborene Herzfehler
Giessen, Hesse, 35385
Not yet recruiting
Universitätsklinikum Tübingen, Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin
Tübingen, Baden-Wurttemberg, 72076
Withdrawn

Other trials in Germany

Austria2 sites, 2 recruiting

Kepler Universitätsklinikum GmbH - Klinik für Kinderkardiologie
Linz, Upper Austria, 4061
Not yet recruiting
Medizinische Universität Wien - Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie
Vienna, State of Vienna, 1090
Not yet recruiting

Other trials in Austria

Czechia2 sites, 2 recruiting

Fakultní nemocnice Brno, Dětská nemocnice - Pediatrická klinika
Brno, South Moravian, 613 00
Not yet recruiting
Fakultní nemocnice Motol a Homolka, Pracoviště MOTOL - Dětské kardiocentrum 2. LF UK a FN Motol
Prague, Prague, 150 06
Not yet recruiting

Other trials in Czechia

Finland1 site, 1 recruiting

HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, kardiologia
Helsinki, Uusimaa, 00290
Not yet recruiting

Other trials in Finland

Hungary1 site, 1 recruiting

Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet - Gyermeksziv Kozpont
Budapest, 1096
Not yet recruiting

Other trials in Hungary

Sweden1 site, 1 recruiting

Skånes Universitetssjukhus - Lund - Barnhjärtcentrum
Lund, Skåne County, 222 41
Not yet recruiting

Other trials in Sweden

About this study

Official title: 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)

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.

Conditions: Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Being tested: Finerenone (Kerendia, BAY94-8862)
Medical subject headings: Ventricular Dysfunction, Left, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Finerenone (Kerendia, BAY94-8862)Drug
Finerenone in different doses, treatment duration will be 270±7 days.

Study groups in NCT07192952
Study group	Role	What they receive
Finerenone Open-Label Safety Extension	Experimental	Participants will receive finerenone treatment. Receives: Drug: Finerenone (Kerendia, BAY94-8862)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Change in NT-proBNP levels
Measured: From baseline to Day 270±7
Change in left ventricular systolic function
Change measured by echocardiogram (%) from baseline to Day 270±7
Measured: From baseline to Day 270±7
Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md)
Measured: 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)
Measured: 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.
Measured: On Day 30±3 and Day 270±7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202630 Dec 2030

First posted25 Sep 2025
Study start1 Jun 2026
Primary completion30 Dec 2030 (estimated)
Study completion30 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Left Ventricular Systolic DysfunctionStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 117 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07192952
Sponsor's protocol ID: 21467
Other IDs: 2024-519830-22-00
Acronym: FIORELLO
Status last verified: 23 Jul 2026
First submitted: 17 Sep 2025
Last updated: 27 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Interested in taking part?

Bayer Clinical Trials Contact

0018888422937

clinical-trials-contact@bayer.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Recruiting
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Coronary Artery Disease, Heart Failure Systolic
RecruitingPhase 3
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
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
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All Left Ventricular Systolic Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT07192952
Acronym / sponsor ID: FIORELLO / 21467
Conditions: Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 117 participants (estimated)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 1 Jun 2026 (actual)
Primary completion: 30 Dec 2030 (estimated)
Study completion: 30 Dec 2030 (estimated)
First posted: 25 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

The doctors will check the participants' health a month after the participants take their last treatment.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Finerenone Open-Label Safety Extension	Experimental	Drug: Finerenone (Kerendia, BAY94-8862)Participants will receive finerenone treatment.

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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 ng/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).

Key exclusion criteria (8 listed)

For participants rolling over from randomized controlled trial (RCT): To roll-over to FIORELLO, all participants: Potassium (K+) >5.5 mmol/L based on local laboratory results. After unblinding:
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 based on local laboratory results at FIORELLO 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Finerenone (Kerendia, BAY94-8862)Finerenone in different doses, treatment duration will be 270±7 days.	Drug	Finerenone Open-Label Safety Extension

Primary outcome

Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From the start of study intervention to last study intervention (up to 277 days) + 3 days
TEAEs will be mapped to Medical Dictionary for Regulatory Activities (MedDRA) terms.
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

5 secondary outcomes

Change in NT-proBNP levels
Time frame: From baseline to Day 270±7
Change in left ventricular systolic function
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
Time frame: On Day 30±3 and Day 270±7

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Bayer Clinical Trials Contact contact

0018888422937

clinical-trials-contact@bayer.com

132 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Finerenone (Kerendia, BAY94-8862) in people with Left Ventricular Systolic Dysfunction and Heart Failure (Pediatric), run by Bayer at 132 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, Argentina, Brazil, Italy, Mexico and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bayer Clinical Trials Contact (0018888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-emergent adverse events (TEAEs) (time frame: From the start of study intervention to last study intervention (up to 277 days) + 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07192952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.