Finerenone for Heart Failure

(FIORELLO Trial)

This trial explores the safety and effectiveness of finerenone for treating heart failure in children and young adults, particularly those with left ventricular systolic dysfunction, where the heart struggles to pump blood effectively. Finerenone blocks a protein that can cause inflammation and scarring in the heart, potentially improving heart function. The trial includes newborns and infants under six months with heart failure and those who participated in a previous study called FIORE. Children and young adults with heart failure symptoms like shortness of breath or fatigue, already receiving standard heart failure treatment, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Participants can continue their standard heart failure treatments while taking finerenone in the study. However, they must not take other mineralocorticoid receptor antagonists like spironolactone or eplerenone within 30 days before starting the trial.

Research has shown that finerenone has been studied for heart failure and has demonstrated promising safety results. In one study, finerenone's safety matched that of a placebo, indicating it did not cause more side effects than a fake treatment. Another study found that finerenone reduced the risk of worsening heart failure and heart-related deaths.

While these results are positive, studies also track any health issues in participants. Researchers frequently check blood pressure, heart rate, and kidney function to ensure the treatment remains safe.

Finerenone is unique because it targets a specific receptor in the kidney known as the mineralocorticoid receptor, which plays a role in fluid and sodium retention linked to heart failure. Unlike traditional treatments like ACE inhibitors or beta-blockers, finerenone offers a novel approach by directly reducing inflammation and fibrosis in heart tissues. Researchers are excited about finerenone because it has the potential to improve heart function with fewer side effects related to potassium levels compared to older mineralocorticoid receptor antagonists.

Research has shown that finerenone can help treat heart failure. In studies, finerenone lowered the risk of death from heart problems and reduced hospital visits for heart failure. For instance, one study found fewer heart-related events in people taking finerenone compared to those who did not. Another study showed that finerenone decreased the number of hospital visits due to heart failure. This treatment works by blocking a protein that causes inflammation and damage in the heart, which may help the heart pump blood more effectively. These findings suggest that finerenone could be a promising option for managing heart failure with left ventricular systolic dysfunction. Participants in this trial will receive finerenone treatment in an open-label safety extension.¹²³⁶⁷