American Regent Announces Enrollment of First Patient in Phase 3 HEART-FID Trial

May 3, 2017 — American Regent, a member of the Daiichi Sankyo Group, announced that the first patient has been enrolled into the phase 3 clinical trial, HEART-FID. This double-blind, multicenter, prospective, randomized, placebo-controlled study will assess the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of patients with heart failure, iron deficiency and a reduced ejection fraction.

“Iron deficiency affects up to half of all heart failure patients and is associated with impaired exercise tolerance, and mortality in patients with or without anemia,²” said Adrian F. Hernandez, M.D., MHS, Duke Clinical Research Institute and HEART-FID study chair. “HEART-FID has the potential to provide a deeper understanding of how intravenous iron may help patients with heart failure with a low ejection fraction.”

Heart failure prevalence has increased from 5.7 million (2009 to 2012) to 6.5 million (2011 to 2014) in Americans ≥20 years of age.³ About half of people who develop heart failure die within five years of diagnosis.⁴

HEART-FID will assess the effects of IV FCM compared to placebo on the following outcome measures:

The 12-month rate of death;
Hospitalization for worsening heart failure; and
The six-month change in six-minute walk test (6MWT) for patients in heart failure with iron deficiency.¹

The study is anticipated to enroll more than 3,000 adult patients across North America.¹

Use of Injectafer as a treatment for heart failure with iron deficiency is investigational and has not been approved by the U.S. Food and Drug Administration (FDA) as such.

For more information: www.americanregent.com

References

Hernandez, A. Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure with Iron Deficiency (HEART-FID). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2017 Mar 26]. Available from: https://clinicaltrials.gov/ct2/show/NCT03037931. NLM Identifier: NCT03037931. [Last accessed: March 2017].
McDonagh, Theresa, and Iain C. Macdougall. "Iron therapy for the treatment of iron deficiency in chronic heart failure: intravenous or oral?" European journal of heart failure. 2015; 17(3):248-262. Available at: https://www.ncbi.nlm.nih.gov/pubmed/25639592. [Last accessed: March 2017].
Benjamin, Emelia J., et al. "Heart disease and stroke statistics—2017 update: a report from the American Heart Association." Circulation 135.10 (2017): e146-e603. Available at: http://circ.ahajournals.org/content/circulationaha/early/2017/01/25/CIR.0000000000000485.full.pdf. [Last accessed: March 2017].
Centers for Disease Control and Prevention. Heart Failure Fact Sheet. 2016. Available at: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/docs/fs_heart_failure.pdf. [Last accessed: March 2017].
Miller, Jeffrey. Iron Deficiency Anemia: A Common and Curable Disease. Cold Spring Harb Perspect Med 2013;3: Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3685880/pdf/cshperspectmed-HMG-a011866.pdf. [Last accessed: March 2017].
Injectafer® [package insert]. Shirley, NY: American Regent, Inc.; 2013.