IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches
Key facts
- Who runs it
- Syed Hamza Mufarrih
- Where
- Bowling Green, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 4
- People taking part
- 42 people enrolled
- Started
- 2 Apr 2025
- Ended
- 31 Mar 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ferric Carboxymaltose
- Ferrous Sulfate
- Record updated
- 20 July 2026
- Why it stopped
- Post-discharge low follow-up (\<50%) rates.
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Vitamin B12 or folate deficiency (unless corrected prior to enrollment)
- 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
- Chronic liver disease (with LFTs >3× upper limit of normal)
- 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
- Pregnant or breastfeeding women or those not using effective contraception
- Lacks capacity to consent or unable to comply with study procedures
Where in United States
- The Medical CenterBowling Green, United States
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- IV Iron (Ferric Carboxymaltose)Treatment being tested
Patients randomized to receive intravenous ferric carboxymaltose. Dosing includes a 1-gram IV infusion during the index hospital stay, followed by a second infusion at Week 6 (1,000 mg if \> 70 kg or 500 mg if ≤ 70 kg).
Treatment: Ferric Carboxymaltose
- Oral Iron (Ferrous Sulfate)Existing treatment, for comparison
Patients randomized to receive one capsule of oral ferrous sulfate (Ferrex 150 mg) every 48 hours for 12 weeks.
Treatment: Ferrous Sulfate
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- IRONICA: IRON Repletion in Congestive Heart Failure - A Randomized Controlled Trial Comparing Oral Versus IV Approaches
- Record updated
- 20 July 2026