RecruitingPhase 4NCT07053475

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

IRONICA: IRON Repletion in Congestive Heart Failure - A Randomized Controlled Trial Comparing Oral Versus IV Approaches


Sponsor

Syed Hamza Mufarrih

Enrollment

250 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial (IRONICA) compares two ways of treating iron deficiency in people with heart failure: iron pills taken by mouth versus iron given through an IV infusion. Iron deficiency is very common in heart failure patients and worsens fatigue and breathlessness. Researchers want to find out which method works better and is more convenient. **You may be eligible if...** - You have been diagnosed with heart failure - You have iron deficiency (low iron levels in your blood) - Your doctor has determined you need iron supplementation - You are 18 or older and able to attend study visits **You may NOT be eligible if...** - You have a known intolerance or allergy to iron supplements - You have recently received IV iron therapy - You have another condition causing iron deficiency that needs separate treatment (like active bleeding) - You have severely impaired kidney function or are on dialysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerric 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).

DRUGFerrous Sulfate

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


Locations(1)

The Medical Center

Bowling Green, Kentucky, United States

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NCT07053475


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