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NCT07192952 · ClinicalTrials.gov registry record · Phase 3
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, sponsored by Bayer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT07192952: Recruiting Phase 3 study, sponsored by Bayer.
NCT07192952 is a Phase 3 study that is actively recruiting participants, run by Bayer. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07192952, a Phase 3 study, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
Study 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 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
Primary Outcome
TEAEs will be mapped to Medical Dictionary for Regulatory Activities (MedDRA) terms.
Interventions
- DRUG Finerenone (Kerendia, BAY94-8862)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2030-12-30 |
| Phase | Phase 3 |
What NCT07192952 shows while recruiting
NCT07192952 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Finerenone (Kerendia, BAY94-8862) is the first listed.
NCT07192952 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07192952 about?
NCT07192952 is a clinical study titled "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". 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 ef...
What is the current status of trial NCT07192952?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2026-06-01. Estimated completion is 2030-12-30.
What interventions are being tested in trial NCT07192952?
The interventions under investigation include: Finerenone (Kerendia, BAY94-8862) (DRUG).
Who is sponsoring clinical trial NCT07192952?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07192952's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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