Evaluating BalcinrenoneDapagliflozin Compared With Dapagliflozin Alone for Heart Failure and Kidney Function Impact

What This Trial Is About

Researchers are conducting a Phase III international study to evaluate the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients with chronic heart failure HF and impaired kidney function who have recently experienced a heart failure event. The study aims to assess the impact of these treatments on cardiovascular death and heart failure events, including hospitalizations and other HF-related episodes. Participants are randomly assigned to one of three groups one receiving balcinrenonedapagliflozin 15 mg10 mg capsule plus placebo another receiving balcinrenonedapagliflozin 40 mg10 mg capsule plus placebo and a third group receiving dapagliflozin 10 mg tablet plus placebo capsule. All treatments are given once daily orally, alongside standard care for heart failure and kidney impairment. The study is conducted across approximately 700 sites in about 40 countries. During the trial, participants will be monitored over approximately 36 months for cardiovascular death, heart failure hospitalizations, and heart failure events without hospitalization. Assessments include heart failure symptom scores measured at 24 weeks post-randomization. Researchers will also track total occurrences of cardiovascular and heart failure events, as well as overall mortality. This long-term follow-up aims to evaluate treatment effects on these important health outcomes.

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function