This randomized controlled trial involved 666 patients with acute decompensated ischemic heart failure. The study took place across 37 hospitals in 20 regions of China. Participants received either Yiqi Fumai lyophilized injection for seven days or guideline-directed medical therapy alone. The main comparison looked at how many patients saw a drop in their B-type natriuretic peptide (BNP) levels by at least 30% on day 8.
The group receiving Yiqi Fumai showed a higher proportion of patients achieving this BNP reduction compared to the control group. The study also reported statistically significant improvements in left ventricular ejection fraction, NYHA functional class, and quality of life scores for those receiving the injection.
No statistically significant difference was found between the groups regarding composite endpoint events or adverse events. The researchers noted that the injection was tolerated without increasing safety risks compared to standard therapy. This trial suggests a potential benefit for this specific patient population regarding BNP reduction and functional measures.