Heart Failure with Iron Deficiency (HEART FID)
This clinical trial is for heart failure patients with low iron levels.
About
Protocol Description
A double-blind, multi-center, prospective, randomized, placebo-controlled study to investigate the efficacy and safety of Injectafer® (ferric carboxymaltose) as treatment for heart failure with iron deficiency: This study will assess the effects of IV FCM compared to placebo on the 12-month rate of death and hospitalization for worsening heart failure, and change in 6MWT at 6 months for patients in heart failure with reduced ejection fraction and with iron deficiency.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years of age
- Stable heart failure
- Able to perform a 6-minute walk test
Exclusion Criteria
- Current or planned oral iron supplementation; iron-containing multivitamins (<30 mg/day) are permitted
- Known hypersensitivity reaction to any component of FCM
- History of acquired iron overload
- Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest)
- Current or planned mechanical circulatory support or heart transplantation
- Hemodialysis or peritoneal dialysis
- Documented liver disease or active hepatitis
- Pregnant or lactating individuals
- Known gastrointestinal bleeding
Primary Investigator
David Sane, M.D.
Professor of Medicine at the Virginia Tech Carilion School of Medicine, chief of Cardiology at Carilion Clinic and program director of the Cardiovascular Disease Fellowship. Dr. Sane has published more than 140 peer-reviewed manuscripts on vascular biology thrombosis and other aspects of basic and clinical cardiovascular disease.
