Effect of thalidomide in patients with chronic heart failure.

BACKGROUND Congestive heart failure (CHF) is characterized by enhanced immune activation, which possibly plays a pathogenic role in this disorder. We therefore examined whether immunomodulation with thalidomide could improve cardiac performance in patients with CHF. METHODS Nine patients with chronic symptomatic CHF and left ventricular ejection fraction (LVEF) <40%, who were receiving "optimal" conventional cardiovascular treatment, were given 200 mg thalidomide daily in an open design for a period of 6 weeks. Tumor necrosis factor (TNF)-alpha and LVEF were measured at baseline and on completion of the study. RESULTS Two patients withdrew because of side effects. Sedation was common and required dose reduction in 6 of 7 patients completing the study. Plasma levels of TNF-alpha were elevated at baseline compared with levels in healthy control patients, but decreased significantly from 33.9 +/- 10.1 pg/mL to 19.3 +/- 6.1 pg/mL during therapy (P <.05). LVEF increased in all patients from 26% +/- 9% to 34% +/- 10% at the end of the observation period (P <.05). CONCLUSIONS In this pilot study, therapy with thalidomide in patients with CHF resulted in decreased TNF-alpha levels and increased cardiac performance. Although few patients were included, our results suggest that thalidomide should be further investigated as an immunomodulating agent in CHF.

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