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Iron infusions put to the test for heart failure stamina

NCT ID NCT05816265

Disease control Sponsor: Radha Gopalan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether a single intravenous iron infusion can improve exercise capacity in people with heart failure and iron deficiency. Participants are randomly assigned to receive the infusion or no treatment, then undergo cardiopulmonary exercise testing to measure peak oxygen uptake. The study also tracks quality of life using a heart-failure questionnaire and a six-minute walk test.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an intravenous iron infusion (ferric carboxymaltose)
What this could lead to
If it works, this could point toward a simple treatment to improve exercise tolerance and quality of life in people with heart failure and low iron.
What could go wrong
This is a very small, early-phase trial with only 6 participants, so results may not apply broadly. Iron infusions carry a small risk of allergic reactions or iron overload.

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

6 people

The number who actually took part.

Started

Jan 2024

Finished

Nov 2025

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 90 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 18-90 years * New York Heart Association Class II-III heart failure * Left ventricular dysfunction with left ventricular ejection fraction ≤ 40% * Ferritin \< 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) \< 20% * Patients deemed by an attending physician to require intravenous iron therapy * The patient is willing and able to comply with the protocol and has provided written informed consent Exclusion Criteria: * Iron overload disorders or allergy, concomitant nutritional deficiencies- B12 and folate * Recent Acute Coronary Syndrome * Physical barriers to exercise capacity * Currently presenting in heart failure exacerbation * Declined participation * Chronic liver disease * NYHA class IV * Active bleeding * Pregnancy * Life expectancy ≤ 12 months

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Conditions

The condition(s) this trial relates to.

heart failure iron deficiency anemia Motor Activity systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Iron-deficiency

Contacts and locations

Locations

  • Banner - University Medical Center, Phoenix campus

    Phoenix, Arizona, 85006, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.