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 : Recruiting
First Posted : January 31, 2017
Last Update Posted : November 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Iron-deficiency||Drug: Ferric carboxymaltose Drug: Placebos||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) 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3014 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|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||June 2022|
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 iron indices
Drug: Ferric carboxymaltose
Other Name: Injectafer, Ferinject
Placebo Comparator: Placebos
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
|Contact: James Marco||631-772-3504 ext 61804||HEART-FID@luitpold.com|
|Contact: Michael Dugan, MD||631-772-3512 ext 61812||HEART-FID@luitpold.com|
Show 201 Study Locations
|Study Chair:||Adrian F Hernandez, MD||Duke Clinical Research Institute|