This study is being performed to see whether an investigational drug TNFR:Fc, or etanercept, is an effective, safe, and well tolerated drug compared to placebo in NYHA class II-IV patients with congestive heart failure. Etanercept is a manmade drug which blocks the action of a protein called tumor necrosis factor, or TNF. TNF is known to be produced by the failing heart, but not by the non-failing heart, and is elevated in patients with congestive heart failure. Based on laboratory and clinical evidence, it is believed that elevated TNF may contribute to the deterioration of heart function in patients with congestive heart failure. As a result, blocking the effects of TNF may improve the status of patients with congestive heart failure. This is a double-blind, placebo-controlled, multicenter dose-ranging, out- patient study in which patients will be randomly assigned to one of three study groups (1:1:1). Patients must be receiving stable therapy for heart failure including a diuretic and an ACE inhibitor (unless there is a history of ACE intolerance or a contraindication to use) and will be pre-screened based upon B-blocker use and NYHA functional class. Group 1 will receive placebo three times weekly. Group 2 will receive etanercept 25 mg twice weekly and placebo once weekly. Group 3 will receive etanercept 25 mg three times weeekly. The study drug will be given subcutaneously (SC) three times weekly, at approximately the same time of day during the treatment period.
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