NCT07053475 · Syed Hamza Mufarrih
IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches
(IRONICA)
What this study 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: given through a vein (IV) (IV) iron given through a vein or taken by mouth (PO) iron taken by mouth.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥18 years
- BMI ≥18.0 kg/m²
- Hemoglobin: \> 9 g/dL and \<14 g/dL for men \> 9 g/dL and \<13 g/dL for women
- Diagnosed with Congestive Heart failure: HFrEF: EF ≤40% in any recent echocardiogram HFpEF: EF ≥50-55% without any prior EF ≤40%, and evidence of diastolic dysfunction per ASE/EACVI 2023 criteria-defined as either grade ≥2 or ≥2 supporting echo parameters (septal e' \<7 cm/sec or lateral e' \<10 cm/sec, E/e' ≥15, TR velocity \>2.8 m/s, LA volume index ≥34 mL/m², LV septal or posterior wall thickness ≥1.2 cm, or LA area ≥20 cm² / diameter ≥3.8 cm.
- Documented elevated NT-proBNP based on BMI and rhythm: BMI \<35: ≥220 pg/mL (NSR) or ≥660 pg/mL (A-Fib) BMI ≥35: ≥125 pg/mL (NSR) or ≥375 pg/mL (A-Fib)
- NYHA Class II-IV
- Transferrin saturation (TSAT) \<20%
- Hemoglobin \<14 g/dL for men, \< 13 g/dL for women.
- Stable on heart failure therapy for ≥2-4 weeks
- Currently prescribed a diuretic at home
- Ambulatory (able to walk \>20 ft with minimal assistance)
- Willing and able to give informed consent
Exclusion criteria
- Received IV iron, ESA, or blood transfusion within the last 6-12 months
- Received high-dose oral iron (\>100 mg/day in past 7 days)
- Severe renal impairment (eGFR \<15 mL/min/1.73 m² or on dialysis)
- Patients with known cirrhosis or transaminitis with AST \>141 or ALT \>112 IU/L
- Active bleeding or known bleeding disorder
- Recent cardiac surgery, myocardial infarction, or stroke within past 3 months
- Active infection, defined as any systemic or deep-seated infection (e.g., bacteremia, sepsis, osteomyelitis, or infections requiring IV antibiotics or hospitalization) at the time of screening.
- Active malignancy or undergoing chemotherapy/radiotherapy
- Vitamin B12 or folate deficiency (unless corrected prior to enrollment)
- Chronic liver disease (with LFTs \>3× upper limit of normal)
- Pregnant or breastfeeding women or those not using effective contraception
- Lacks capacity to consent or unable to comply with study procedures
Where
- Bowling Green, Kentucky
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2025 · Source of record for eligibility and locations