Non-specific immunomodulation therapy may benefit select patients with chronic heart failure through suppression of inflammation, according to an article in the January 19 issue of Lancet.

The ACCLAIM trial randomized 2,400 patients with chronic heart failure to the Celacade(TM) immunomodulation system or placebo. Although the study did not meet its primary endpoint of the composite of time to death from any cause or first hospitalization for cardiovascular reasons, the device-based system, which was administered by intragluteal injection, did benefit certain subgroups.

Two pre-defined subgroups did benefit significantly: Risk for all-cause death and first hospitalization for cardiovascular reasons was significantly decreased in the 689 patients with Class II heart failure (by 39 percent) and the 919 patients with no prior history of myocardial infarction (by 26 percent). Importantly, the large risk reduction observed in these subgroups was achieved on top of the benefits derived from current standard-of-care medications and device therapy for heart failure.

The authors wrote that "Non-specific immunomodulation (Celacade) may have a role as a potential treatment for a large segment of the heart failure population, which includes patients without a history of myocardial infarction (irrespective of their functional New York Heart Association class and patients within NYHA class II."

The ACCLAIM-II trial, to be conducted with patients with Class II heart failure, is being planned for the purpose of achieving regulatory approval in the United States.