Vicadrostat + Empagliflozin for Heart Failure

This trial tests whether a new medicine combination can help people with chronic heart failure feel better and live longer. It examines the use of vicadrostat (a potential new drug) with empagliflozin compared to a placebo (a pill that looks the same but contains no medicine) alongside empagliflozin. Suitable participants have had chronic heart failure for at least three months and a heart condition called reduced ejection fraction, where the heart pumps less blood with each beat. Participants will continue their usual heart failure treatments and regularly check in with study staff. The trial aims to determine if the medicine combination can reduce hospital visits and improve heart health. 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.

You can continue your regular treatment for heart failure during the study, but you cannot take certain medications like mineralocorticoid receptor antagonists (e.g., spironolactone) or potassium-sparing diuretics within 14 days before starting the trial. Some other specific medications are also not allowed during the trial.

Research has shown that empagliflozin is generally safe. It has been tested in individuals with type 2 diabetes and kidney problems, and most tolerated it well with only minor side effects. This suggests it is safe for similar conditions.

Studies on vicadrostat are still ongoing. It is being tested for heart and kidney benefits. Although complete safety details are not yet available, its late-stage testing indicates that earlier tests did not find major safety issues.

Researchers are excited about the combination of Vicadrostat and Empagliflozin for heart failure because it targets the condition in a novel way. Unlike traditional treatments that focus solely on managing symptoms or fluid balance, Vicadrostat acts as an aldosterone synthase inhibitor, potentially reducing heart stress and damage. When paired with Empagliflozin, a well-known SGLT2 inhibitor that helps reduce heart failure risks by managing blood sugar and exerting protective effects on the heart and kidneys, this combination could offer a more comprehensive approach to heart failure management. This dual-action strategy may enhance heart function and offer new hope for patients with heart failure.

This trial will evaluate the combination of vicadrostat and empagliflozin for treating heart failure. Research has shown that this combination may help manage heart failure. Studies have found that vicadrostat can reduce urinary protein levels by about 40% when used with SGLT2 inhibitors like empagliflozin. Lower protein levels in urine indicate improved heart and kidney health. Empagliflozin is already known to aid heart failure patients by reducing hospital visits and enhancing heart function. The combination of these two drugs aims to amplify these benefits, potentially leading to better outcomes for heart failure patients.³⁴⁵⁶⁷