Iron showdown: IV vs. pills for heart failure fatigue
NCT ID NCT07053475
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This trial tests whether intravenous (IV) iron or oral iron pills work better for adults with congestive heart failure who also have low iron levels. Participants are randomly assigned to receive either a one-time IV infusion of ferric carboxymaltose (with a possible repeat dose) or twice-daily ferrous sulfate capsules for 24 weeks. The study measures walking distance, symptoms, quality of life, and safety to help doctors choose the best iron treatment for this group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ferric carboxymaltose (IV iron) and ferrous sulfate (oral iron)
- What this could lead to
- If IV iron proves superior, it could become the standard way to treat iron deficiency in heart failure, improving patients' ability to walk and quality of life.
- What could go wrong
- This is a small, single-center trial, so results may not apply broadly. IV iron carries rare risks like allergic reactions, and oral iron may cause stomach upset.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
42 people
The number who actually took part.
- Started
-
Apr 2025
- Finished
-
Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Medical Center
Bowling Green, Kentucky, 42101, United States
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Other studies related to the condition(s) this trial covers.
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