Trial Scout

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency

Study Location

Northtowns Cardiology

ClinicalTrials.gov Identifier: NCT03037931
Recruitment Status: Recruiting
First Posted: 1/31/2017 12:00:00 AM
Last Update Posted: 3/14/2019 12:00:00 AM

Study Description

Eligibility Criteria

Additional Contacts

Brief Summary

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

Condition or Disease

Anemia, Iron-Deficiency
Heart Failure

Intervention/Treatment

Drug: Placebos / Normal Saline Solution

Phase

Phase 3

Detailed Description

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. After an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment. Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. In a subset of sites, all participants will return for recurrent laboratory assessment (chemistry, hematology and iron indices) at Day 21 (± 7) after each course of investigational treatment. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.

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