Condition: Left Ventricular Systolic Dysfunction · Heart Failure (Pediatric) · Sponsor: Bayer
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 you…
This description comes directly from the study's public registry record.
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| Children's Hospital Colorado - Anschutz Medical Campus - Cardiology | Aurora, Colorado, United States | Not Yet Recruiting |
| Nemours Children's Hospital - Delaware - Cardiology | Wilmington, Delaware, United States | Not Yet Recruiting |
| UF Health Shands Hospital - Pediatric Cardiology | Gainesville, Florida, United States | Not Yet Recruiting |
| Joe Dimaggio Children's Hospital - Cardiology | Hollywood, Florida, United States | Not Yet Recruiting |
| Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta | Atlanta, Georgia, United States | Not Yet Recruiting |
| Riley Hospital For Children - Cardiology | Indianapolis, Indiana, United States | Not Yet Recruiting |
| Boston Children's Hospital - Main Campus - Cardiology | Boston, Massachusetts, United States | Not Yet Recruiting |
| C.S. Mott Children's Hospital - Cardiology | Ann Arbor, Michigan, United States | Not Yet Recruiting |
| Children's Mercy Hospital Kansas City - Cardiology | Kansas City, Missouri, United States | Not Yet Recruiting |
| Washington University - St. Louis Children's Hospital - Cardiology | St Louis, Missouri, United States | Not Yet Recruiting |
| Icahn School of Medicine at Mount Sinai - Pediatric Cardiology | New York, New York, United States | Not Yet Recruiting |
| Columbia University Irving Medical Center - Pediatric Cardiology | New York, New York, United States | Not Yet Recruiting |
+ 120 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07192952