Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency (HEART-FID)
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|ClinicalTrials.gov Identifier: NCT03037931|
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : April 26, 2023
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Iron-deficiency||Drug: Ferric Carboxymaltose Drug: Placebo||Phase 3|
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) distance 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, a sub-study will be conducted to characterize serum phosphate levels over time in participants with heart failure and iron deficiency after dosing with FCM. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3065 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||March 15, 2017|
|Actual Primary Completion Date :||February 2, 2023|
|Actual Study Completion Date :||February 2, 2023|
Active Comparator: Ferric Carboxymaltose
Ferric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by the results of iron indices.
Drug: Ferric Carboxymaltose
Other Name: Injectafer, Ferinject
Placebo Comparator: Placebo
Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.
Normal Saline Solution
Other Name: Saline solution
- Incidence of death [ Time Frame: 1 year ]
- Incidence of hospitalization for heart failure [ Time Frame: 1 year ]
- Change in 6MWT distance [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037931
|Study Chair:||Adrian F Hernandez, MD||Duke Clinical Research Institute|