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Iron Supplement
Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study (HEART-FID Trial)
New Orleans, LA
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
Pivotal 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.
See full description
Eligible Conditions
- Heart Failure
- Anemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in 6MWT (Six Minute Walk Test) Distance
Number of Deaths
Number of Hospitalizations for Heart Failure
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Closest Location:Tulane Heart & Vascular Institute· New Orleans, LA
Who is running the clinical trial?
Duke Clinical Research InstituteOTHER
68 Previous Clinical Trials
239,426 Total Patients Enrolled
8 Trials studying Heart Failure
14,374 Patients Enrolled for Heart Failure
American Regent, Inc.Lead Sponsor
61 Previous Clinical Trials
16,262 Total Patients Enrolled
1 Trials studying Heart Failure
40 Patients Enrolled for Heart Failure
Adrian F Hernandez, MDStudy ChairDuke Clinical Research Institute