A Phase 3 interventional study of Finerenone (Kerendia, BAY94-8862) in Left Ventricular Systolic Dysfunction and Heart Failure (Pediatric), sponsored by Bayer. Recruiting at 132 sites in 23 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
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:
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.
260 studies on the registry are indexed under Ventricular Dysfunction, Left; 57 are open to participants now.
This study's planned enrollment of 117 is above the median of 100 across 151 interventional studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 15, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive finerenone treatment.
Drug: Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 270±7 days.
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
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
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Showing the first 100 of 132 sites across 23 countries. Choose a country and city above to see the rest.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Finerenone
Ventricular Dysfunction, Left →