Iron showdown: IV vs. pills for heart failure fatigue

NCT ID NCT07053475

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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