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CLINICAL TRIALS

Effects of a novel immune modulation therapy in patients with advanced chronic heart failure

Results of a randomized, controlled, phase II trial

Guillermo Torre-Amione, MD, PhD, FACC^*,*, François Sestier, MD, Branislav Radovancevic, MD and James Young, MD

^* Methodist DeBakey Heart Center, Baylor College of Medicine, Houston, Texas, USA
Hotel-Dieu du CHUM, Montreal, Quebec, Canada
Texas Heart Institute, Houston, Texas, USA
The Cleveland Clinic Foundation, Cleveland, Ohio, USA

Manuscript received January 15, 2004; revised manuscript received June 3, 2004, accepted June 14, 2004.

^* Reprint requests and correspondence: Dr. Guillermo Torre-Amione, Methodist DeBakey Heart Center and Baylor College of Medicine, 6550 Fannin, Suite 1901, Houston, Texas 77030 (Email: gtorre{at}bcm.tmc.edu).

OBJECTIVE: 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).

BACKGROUND: Immune activation contributes to the progression of HF, but treatments directed against inflammation have been largely unsuccessful.

METHODS: 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.

RESULTS: 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).

CONCLUSIONS: 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.

Abbreviations and Acronyms   HF = heart failure   IMT = immune modulation therapy   LVEF = left ventricular ejection fraction   NYHA = New York Heart Association   TNF = tumor necrosis factor

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