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Protocol No.: 1VIT15043 version: 1.0, 12 January 2017
Inclusion Criteria:
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency
Ferric Carboxymaltose (Injectafer®)
The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency.
This is a double-blind, multicenter, prospective, randomized, placebo- controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) for patients in heart failure with iron deficiency.