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Non-Specific Immunomodulation Could Be Used to Treat Patients withHeart Failure (Acclaim Trial)

LONDON, Jan. 18, 2008--Modifying the immune response in patients with heart failure reduces the risk of death from any cause or subsequent first hospitalisation for cardiovascular reasons. Such non-specific immunomodulation therapy (IMT) could have a role for treating large numbers of these patients. These are the conclusions of authors of an Article in this week’s edition of The Lancet.

Activation of the immune system in patients with systolic heart failure is associated with increased circulating and tissue concentrations of inflammatory cytokines and the presence of autoantibodies specific for a range of cardiac antigens. Animal research suggests some of these molecules could injure the heart in a way that could lead to heart failure. Thus, modulation of this immune response is an appealing therapeutic target.

Professor Guillermo Torre-Amione, Methodist DeBakey Heart Centre at The Methodist Hospital, Houston, Texas, USA, and colleagues did a double-blind, placebo-controlled study of a device-based IMT of 2426 patients. All the patients had New York Heart Association (NYHA) functional class II-IV chronic heart failure, left ventricular systolic dysfunction, and hospitalisation for heart failure or intravenous drug therapy in an outpatient setting within the past 12 months. Patients were randomised to receive IMT (1213) or placebo (1213). The study went on until at least all patients had been treated for 22 weeks, and the primary endpoint was death (from any cause) or subsequent first hospitalisation for cardiovascular reasons.

During a mean follow-up of 10·2 months, there were 399 primary events in the IMT group and 429 in the placebo group, giving a reduction of risk in the IMT group of 8%. However, in two prespecified subgroups of patients—those with no history of heart attack (919) and those with NYHA II heart failure (689), IMT was associated with a 26% and 39% reduction in the risk of primary events, respectively.

The authors conclude: "Our findings suggest a role for non-specific immunomodulation as a potential treatment for a large segment of the heart failure population—including patients without a history of myocardial infarction and those within NYHA class II. However, this hypothesis needs to be tested in an adequately powered confirmatory trial."

Posted: January 2008