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Iron Supplement

Ferric Carboxymaltose for Heart Failure (HEART-FID Trial)

Phase 3
Waitlist Available
Research Sponsored by American Regent, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

HEART-FID Trial Summary

This trial is testing if FCM is an effective and safe treatment for heart failure with a reduced ejection fraction and iron deficiency, compared to placebo.

Eligible Conditions
  • Heart Failure
  • Iron-Deficiency Anemia

HEART-FID Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 6MWT distance
Incidence of death
Incidence of hospitalization for heart failure

HEART-FID Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Ferric CarboxymaltoseActive Control1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.

Find a Location

Who is running the clinical trial?

Duke Clinical Research InstituteOTHER
62 Previous Clinical Trials
237,467 Total Patients Enrolled
7 Trials studying Heart Failure
14,075 Patients Enrolled for Heart Failure
American Regent, Inc.Lead Sponsor
60 Previous Clinical Trials
16,050 Total Patients Enrolled
1 Trials studying Heart Failure
40 Patients Enrolled for Heart Failure
Adrian F Hernandez, MDStudy ChairDuke Clinical Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why is Ferric Carboxymaltose often prescribed?

"Ferric Carboxymaltose can help address iron deficiency, problems within the oral cavity, and difficulties associated with breast feeding."

Answered by AI

How many individuals are being researched in this clinical trial?

"This clinical trial is no longer enrolling patients. The first posting was on March 15th, 2017 and the most recent edit was on November 12th, 2021. 801 other trials are actively recruiting patients with heart failure and 22 studies are looking for participants that have been diagnosed with Ferric Carboxymaltose."

Answered by AI

Are there any other published studies that have used Ferric Carboxymaltose?

"Ferric Carboxymaltose was first studied in 2016. Since the completion of the first trial, there have been 18,338 more. There are currently 22 active trials, a few of which are based in Alexander City, Alabama."

Answered by AI

Who else is applying?

What state do they live in?
Arkansas
Texas
Other
Florida
How old are they?
18 - 65
What site did they apply to?
Sparks Regional Medical Center
Pinehurst Medical Clinic, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
~383 spots leftby Mar 2025