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

Stopped early · Phase 4

Conditions studied: Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure With Preserved Ejection Fraction (HFPEF), Iron Deficiency, Iron-deficiency Anemia (IDA)

In brief

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.

Key facts

Study ID: NCT07053475
Run by: Syed Hamza Mufarrih
People needed: 42
Starts: 2025-04-02
Expected to finish: 2026-03-31
Last updated by the study team: 2026-07-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

The Medical Center — Bowling Green, Kentucky, United States

Full record on ClinicalTrials.gov

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