MedTrace Logo

IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches

NCT07053475 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-07-08

No results posted yet for this study

Summary

The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent.

The main questions the study will answer are:

1. Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks?
2. Does IV iron improve symptoms and quality of life more than oral iron?
3. How do the two treatments compare for safety, side effects, and hospital readmissions/ mortality?

Researchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better.

What participants will do

* Be randomly assigned by (like flipping a coin) to IV iron or oral iron.
* Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks.
* Visit the infusion clinic at 6 weeks for second dose of IV iron if needed.
* Visit the clinic at 12 weeks for a follow-up to gather follow-up data including

1. A 6-minute walk test
2. Brief symptom and quality-of-life surveys
3. Blood tests to measure serum iron, ferritin, and transferrin saturation

This study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.

Conditions

  • Heart Failure
  • Heart Failure With Reduced Ejection Fraction (HFrEF)
  • Heart Failure With Preserved Ejection Fraction (HFPEF)
  • Iron Deficiency
  • Iron-deficiency Anemia (IDA)

Interventions

DRUG

Ferric Carboxymaltose

Intravenous infusion of 1 gram FCM during index hospital stay, followed by a second dose at Week 6 (1,000 mg if \> 70 kg or 500 mg if ≤ 70 kg).

DRUG

Ferrous Sulfate

Oral administration of one 150 mg capsule every 48 hours for 12 weeks.

Sponsors & Collaborators

  • American Regent, Inc.

    collaborator INDUSTRY

  • Syed Hamza Mufarrih

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07053475 on ClinicalTrials.gov