Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Medical Center
Bowling Green, Kentucky, United States, 42101
Actively Recruiting
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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