April 24, 2017 – The study is one of the largest to look at intravenous ferric carboxymaltose iron therapy as a treatment for heart failure in patients with iron deficiency.
HEART-FID, a double-blind, multicenter, prospective, randomized, placebo-controlled study, has enrolled its first patient. The 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,” said the DCRI’s Adrian F. Hernandez, MD, MHS, 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 and older. About half of people who develop heart failure die within five years of diagnosis.
Approximately ten million people are iron deficient in the United States. Iron deficiency is also a common comorbidity that affects up to 50 percent of heart failure patients. HEART-FID is one of the largest clinical trials to look at iron therapy as a treatment for heart failure in patients with iron deficiency.
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 for patients in heart failure with iron deficiency. The study is anticipated to enroll more than 3,000 adult patients across North America.
“We are pleased to enroll our first patient in the HEART-FID trial, one of the largest studies looking at this specific condition, and we look forward to further recruitment,” said Sumita Chowdhury, MD, MPH, FACC, MBA, Head of Clinical Research and Development at American Regent. “Heart failure in relation to iron deficiency is an important area of research for American Regent.”