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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

View larger version (39K): [in a new window]   Figure 1 Randomization and flow of patient evaluations. IMT = immune modulation therapy; LVAD = left ventricular assist device.

View larger version (13K): [in a new window]   Figure 2 Kaplan-Meier estimates of the probability of survival in the immune modulation therapy and placebo groups. The difference was significant (p = 0.022; log-rank test).

View larger version (15K): [in a new window]   Figure 3 Kaplan-Meier estimates of the probability of hospitalization-free survival in immune modulation therapy versus placebo groups. The difference was significant (p = 0.008; log-rank test).

View larger version (15K): [in a new window]   Figure 4 Changes in a clinical composite score from baseline to follow-up visit after six months of treatment with immune modulation therapy (solid bars) or placebo (open bars).