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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

Study acronym: FIORE
StatusRecruiting
PhasePhase 3
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites revised (133)v11 See this version in full on ClinicalTrials.gov ↗
  2. Minor Study sites revised (133)v10 See this version in full on ClinicalTrials.gov ↗
  3. Minor Study sites revised (133)v9 See this version in full on ClinicalTrials.gov ↗
  4. Minor Study sites revised (133)v8 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study sites: 132 to 133v7
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  1. Minor Study sites revised (132)v6 See this version in full on ClinicalTrials.gov ↗
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 28, 2025 to Nov 19, 2025 · Study sites revised (132)v5 Show 2 more changesShow less
    • Start date changed from estimate of Nov 28, 2025 to Nov 19, 2025
    • Study sites revised (132)

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Start date: Oct 30, 2025 to Nov 28, 2025v4
  4. Minor Study sites revised (132)v3 See this version in full on ClinicalTrials.gov ↗
  5. Notable Start date: Sep 30, 2025 to Oct 30, 2025 Study sites revised (132)v2 Show 1 more changeShow less
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure is a serious condition where the heart is unable to pump enough blood to meet the body's needs. This can lead to symptoms like shortness of breath, fatigue, and poor growth in children. The study treatment, finerenone (also called BAY94-8862), works by blocking a protein involved in inflammation, scarring, and thickening of the heart and blood vessels. This may help the heart to pump blood more effectively. This is the first study to explore its use specifically for children with heart failure and LVSD. The main purpose of this study is to learn if finerenone works to help the heart compared to placebo in children with heart failure and LVSD. For this, the researchers will collect and analyze data on the levels of a protein called NT-proBNP in the blood, which indicates heart stress, and monitor the safety of the treatment. The study will include children with heart failure and LVSD aged from 6 months to less than 18 years. The study participants will be randomly assigned to one of two treatment groups. Based on their group, they will receive either finerenone or a placebo for a duration of 3 months. A placebo looks like a treatment but does not have any medicine in it. Throughout the study, all participants will continue to receive their standard heart failure treatments. At the start of this study, the doctors will check each participant's medical history and current medications. If participants qualify for the treatment phase, they will undergo treatment for about 90 days. During this time, they will visit the study site at least 3 times. During these visits, the participants will: * have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured * have their heart examined by electrocardiogram (ECG) and echocardiogram * have blood samples taken * have physical examinations * answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answers 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. After the initial three-month study, eligible participants will have the option to join a nine-month open-label extension study where all will receive finerenone. Participants who choose not to enroll in the extension will have a follow-up visit 30 days after their last treatment.
Trial Details
NCT Number NCT07188805
Lead Sponsor Bayer
Conditions Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov