Open Label Single Arm Pilot Study to Assess Feasibility and Safety of Iron Repletion with Feraheme in Iron Deficient Patients with durable Ventricular Assist Device support

Brief description of study

The purpose of this study is to test the feasibility of an intravenous (IV, given through a vein) medicine (Ferumoxytol) to replace iron in patients with ventricular assist devices (VAD) who have blood test results showing low iron stores (iron deficiency). Heart failure is a condition in which abnormal pumping action of the heart reduces the flow of blood to the body. VADs are used to support the flow of blood in patient with heart failure who were not responding well to other available medical therapies. Iron is an important nutrient that is frequently decreased in VAD patients due to surgery and loss of blood from the stomach or intestines. Iron deficiency can worsen anemia and cause patients to feel fatigued. Ferumoxytol (name brand Feraheme®) is an intravenous medicine that can replenish iron levels with two doses given about one week apart. The purpose of this study is to determine whether two doses of Ferumoxytol can safely replenish iron levels in VAD patients with iron deficiency. Ferumoxytol is approved for use in the United States by the Food and Drug Administration (FDA) for the treatment of iron deficiency, but has not been previously used in VAD patients. Ferumoxytol will be used according to the doses and instructions approved in the United States, but its use is considered to be investigational for this study of its effects in VAD patients.

Clinical Study Identifier: s19-00866

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