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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
NCT07188805 · View on ClinicalTrials.gov ↗
Study Summary
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 * answe
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Finerenone (Kerendia, BAY94-8862)
Study Locations (20)
New York
- Icahn School of Medicine at Mount Sinai - Pediatric Cardiology — New York
- Columbia University Irving Medical Center - Pediatric Cardiology — New York
- The Children's Hospital at Montefiore - Cardiology — The Bronx
Ohio
- Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension — Cincinnati
- Cleveland Clinic Children's — Cleveland
- Nationwide Children's Hospital - Cardiology — Columbus
Florida
- UF Health Shands Hospital - Pediatric Cardiology — Gainesville
- Joe Dimaggio Children's Hospital - Cardiology — Hollywood
Missouri
- Children's Mercy Hospital Kansas City - Cardiology — Kansas City
- Washington University - St. Louis Children's Hospital - Cardiology — St Louis
Pennsylvania
- Children's Hospital of Philadelphia - Cardiology — Philadelphia
- UPMC Children's Hospital of Pittsburgh - Cardiology — Pittsburgh
Colorado
- Children's Hospital Colorado - Anschutz Medical Campus - Cardiology — Aurora
Delaware
- Nemours Children's Hospital - Delaware - Cardiology — Wilmington
Georgia
- Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2025-11-19 |
| Est. Completion | 2029-12-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07188805
The ClinicalTrials.gov registry entry for NCT07188805 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Left Ventricular Systolic Dysfunction appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07188805 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, Ohio, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07188805 about?
NCT07188805 is a clinical study titled "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". 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, fatig...
What is the current status of trial NCT07188805?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2025-11-19. Estimated completion is 2029-12-30.
What conditions does trial NCT07188805 study?
This clinical trial studies the following conditions: Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07188805?
The interventions under investigation include: Placebo (DRUG), Finerenone (Kerendia, BAY94-8862) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07188805?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07188805 being conducted?
This trial has 20 study locations across Colorado, Delaware, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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