At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Finerenone (Kerendia, BAY94-8862) (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Finerenone (Kerendia, BAY94-8862) — drug: Finerenone in different doses, treatment duration will be 270±7 days.
- Patient visit burden
- "During this period, at least 6 visits are planned for participants." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- Up to 18 Years
- Who
- All
- Number of participants
- 117
- Started
- 2026-06-01
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for left ventricular systolic dysfunction
- • Phase3 - 117 participants
- • Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD)
Who can take part?
- • Ages Up to 18 Years
- • Diagnosed with left ventricular systolic dysfunction
Where?
- • Leicester - University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility
- • Liverpool - Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility
- • Belfast - Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology
- • Glasgow - NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Up to 18 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a body weight of ≥3 kg at Visit 1
What the study is looking for
- ✓For newly enrolled infants \<6 months of age: Left ventricular systolic dysfunction (LVSD) with left ventricular...
- ✓For newly enrolled infants \<6 months of age: Elevated NT-pro BNP levels (\> 500 mg/L) at screening.
- ✓Newly enrolled newborns and infants \< 6 months of age must have a body weight of ≥3 kg at Visit 1.
Who cannot take part
- ✗For participants rolling over from randomly assigned controlled trial (RCT): To roll-over to FIORELLO, all participants:...
- ✗For participants who received finerenone in FIORE: K+ \>5.5 mmol/ L
- ✗For newly enrolled newborns and infants \< 6 months of age: Potassium ≥ 5.3 mmol/l (if eGFR is \<60 mL/min/1.73m²,...
- ✗For participants rolling over from RCT: Severe kidney dysfunction with estimated glomerular filtration rate (eGFR) \<...
- ✗For newly enrolled infants \< 6 months of age: Severe kidney dysfunction with eGFR \< 30 ml/min/1.73m2 at screening...
See the full criteria
Where Is This Study? (7 UK sites)
University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility
Liverpool L122AP, United Kingdom
Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology
Belfast BT12 6BE, United Kingdom
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
Glasgow G51 4TF, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit
Newcastle upon Tyne NE7 7DN, United Kingdom
Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility
Leeds LS1 3EX, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility
Bristol BS2 8AE, United Kingdom
How to Get in Touch
Bayer Clinical Trials Contact
Sponsor contactCONTACT
