Effects of a novel immune modulation therapy in patients with advanced chronic heart failure: Results of a randomized, controlled, phase II trial

54Citations
Citations of this article
30Readers
Mendeley users who have this article in their library.

Abstract

We sought to determine whether a novel, non-pharmacological form of immune modulation therapy (IMT), shown experimentally to reduce inflammatory and increase anti-inflammatory cytokines, improved outcomes in patients with advanced heart failure (HF). Immune activation contributes to the progression of HF, but treatments directed against inflammation have been largely unsuccessful. Seventy-five HF patients (New York Heart Association [NYHA] functional class III to IV) were randomized to receive either IMT (n = 38) or placebo (n = 37) in a double-blind trial for six months, with continuation of standard HF therapy. Patients were evaluated using the 6-min walk test, changes in NYHA functional class, cardiac function, and quality of life assessments, as well as occurrence of death and hospitalization. There was no between-group difference in 6-min walk test, but 15 IMT patients (compared with 9 placebo) improved NYHA functional classification by at least one class (p = 0.140). The Kaplan-Meier survival analysis showed that IMT significantly reduced the risk of death (p = 0.022) and hospitalization (p = 0.008). Analysis of a clinical composite score demonstrated a significant between-group difference (p = 0.006). There was no difference in left ventricular ejection fraction, but there was a trend toward improved quality of life (p = 0.110). These preliminary findings are consistent with the hypothesis that immune activation is important in the pathogenesis of HF and establish the basis for a phase III trial to define the benefit of IMT in chronic HF. © 2004 by the American College of Cardiology Foundation.

Cite

CITATION STYLE

APA

Torre-Amione, G., Sestier, F., Radovancevic, B., & Young, J. (2004). Effects of a novel immune modulation therapy in patients with advanced chronic heart failure: Results of a randomized, controlled, phase II trial. Journal of the American College of Cardiology, 44(6), 1181–1186. https://doi.org/10.1016/j.jacc.2004.06.047

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Save time finding and organizing research with Mendeley

Sign up for free