Actively Recruiting

Phase 4
Age: 18Years - 100Years
All Genders
NCT07053475

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

Led by Syed Hamza Mufarrih · Updated on 2025-07-08

250

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

S

Syed Hamza Mufarrih

Lead Sponsor

A

American Regent, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Body mass index (BMI) 18.0 kg/m² or higher
  • Hemoglobin between 9 and 14 g/dL for men, and between 9 and 13 g/dL for women
  • Diagnosed with congestive heart failure with reduced ejection fraction (EF ≤ 40%) or preserved ejection fraction (EF 50-55%) with evidence of diastolic dysfunction
  • Elevated NT-proBNP levels based on BMI and heart rhythm
  • New York Heart Association (NYHA) Class II to IV
  • Transferrin saturation (TSAT) below 20%
  • Hemoglobin below 14 g/dL for men and below 13 g/dL for women
  • Stable on heart failure therapy for 2 to 4 weeks
  • Currently prescribed a diuretic at home
  • Able to walk more than 20 feet with minimal assistance
  • Willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Received intravenous iron, erythropoiesis-stimulating agents, or blood transfusion within the last 6 to 12 months
  • Taken high-dose oral iron (more than 100 mg/day) in the past 7 days
  • Severe kidney impairment (eGFR below 15 mL/min/1.73 m²) or on dialysis
  • Known liver cirrhosis or elevated liver enzymes (AST over 141 or ALT over 112 IU/L)
  • Active bleeding or bleeding disorder
  • Recent cardiac surgery, heart attack, or stroke within the past 3 months
  • Active infection requiring hospitalization or intravenous antibiotics
  • Active cancer or currently receiving chemotherapy or radiotherapy
  • Vitamin B12 or folate deficiency unless corrected before joining
  • Chronic liver disease with liver function tests more than 3 times the upper limit of normal
  • Pregnant or breastfeeding women or those not using effective contraception
  • Unable to give consent or comply with study procedures

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Medical Center

Bowling Green, Kentucky, United States, 42101

Actively Recruiting

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Research Team

S

Syed H Mufarrih, MD

CONTACT

M

Melinda Joyce

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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