Advanced Chronic Heart Failure Clinical Assessment of Immune Modulation Therapy - ACCLAIM
The goal of the trial was to evaluate treatment with immunotherapy compared with placebo among patients with chronic heart failure (CHF).
Patients Enrolled: 2,426
Mean Patient Age: Mean age 64 years
Age ≥18 years, left ventricular ejection fraction ≤30% within the prior 6 months, NYHA class II-IV on standard HF therapy, and no change in cardiac medication in 2 weeks prior to randomization
Mortality or cardiovascular (CV) hospitalization
All-cause death and all-cause hospitalizations; all-cause death and heart failure hospitalizations
Patients were randomized in a double-blind manner to treatment with immunotherapy (n = 1,213) or placebo (n = 1,213). Immunotherapy was administered using the Celacade System, which involved an ex vivo treatment of 10 ml of autologous blood with controlled oxidative stress followed by intramuscular administration of the sample. Treatment was performed on days 1, 2, 14, and every 28 days thereafter until the end of the study. All patients were also to receive standard therapy for HF.
At baseline, mean ejection fraction was 22.7%, 69% of patients had ischemic heart failure, and 62% had a prior myocardial infarction (MI). Concomitant medication use was high, with 94% of patients on an angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker, 87% on beta-blocker, 94% on diuretics, and 44% on digoxin.
There was no difference in the primary endpoint of death or cardiovascular (CV) hospitalization between immune modulation therapy (IMT) and placebo (33.1% for IMT and 35.6% for placebo, p = 0.22). There was no difference in mortality (10.6% for IMT vs. 9.6% for placebo, p = NS). There was also no difference in the occurrence of ≥1 serious adverse event (44.8% vs. 46.7%, p = NS).
Among the subgroup of patients with New York Heart Association (NYHA) class II (n = 689), death or CV hospitalization was lower with IMT compared with placebo (hazard ratio 0.61, p = 0.0003).
Among patients with CHF, treatment with IMT was not associated with a difference in the primary endpoint of death or CV hospitalization compared with placebo.
While there was no difference in the total population, benefit with IMT was observed in the subgroup of patients with NYHA class II HF, although these findings would need further confirmation given the negative findings of the trial overall.
Torre-Amione G, Anker SD, Bourge RC. Results of a non-specific immunomodulation therapy in chronic heart failure (ACCLAIM trial): a placebo-controlled randomised trial. Lancet. 2008 Jan 19;371(9608):228-36.
Keywords: Myocardial Infarction, Digoxin, Immunotherapy, Diuretics, Heart Failure, Oxidative Stress, Stroke Volume, Hospitalization
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