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Iron shots after valve surgery: could they boost energy and walking ability?

NCT ID NCT07370688

Symptom relief Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving iron infusions after a minimally invasive heart valve replacement (TAVI) helps patients with aortic stenosis and iron deficiency feel better and walk farther. About 402 older adults will be randomly assigned to receive iron or standard care. Researchers will measure quality of life and exercise capacity 24 weeks after the procedure.

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 (iron infusion)
What this could lead to
If it works, this could show that correcting iron deficiency after TAVI helps patients feel better and walk farther.
What could go wrong
This is a Phase 4 trial, but the benefit of iron in this setting is not proven. Some patients may not improve, and iron infusions carry rare risks like allergic reactions.

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

About 402 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

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

65 years and older

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: * Patient age ≥ 65 years * Patients with severe AS and ID undergoing successful TAVI * ID defined as Ferritin \< 100 ug/L and/or Transferrin saturation \< 20% * Ability to perform assessment of QoL (questionnaire assessment) and EC (6-MWT) * Signed Informed Consent Exclusion Criteria: * Contra-indication for TAVI * Ferritin \> 400 ug/L * Hemoglobin \<5.6 mmol/L or \<9 g/dL * Hemoglobin \>8.7 mmol/L or \>14 g/dL in men and \>8.1 mmol/L or \>13 g/dL in women * Anaemia due to known reasons other than ID and/or anticipated non-response to iron-supplementation (e.g. hemogobinopathy, bone marow disease, active cancer, unresolved active bleeding) * Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range. * Renal dialysis (previous, current, or planned within the next 6 months) or MDRD/CKD-EPI estimated glomerular filtration rate \<15 mL/min. * History of iron overload * History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 3 months and/or such therapy planned within next 6 months * Clinically apparent infection requiring antibiotic treatment * Known hypersensitivity to iFCM or to any of its excipients * Pregnancy * Study subject participation in another TAVI related clinical study in which the primary endpoint includes mortality, hospitalization for heart failure and/or quality of life assessment.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis cardiovascular disorder Iron Deficiencies iron deficiency anemia

As listed by the trial registrant

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

Aortic valve stenosis Cardiovascular diseases Iron-deficiency Tavi(transcatheter aortic valve implantation)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erasmus University Medical Center

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

More trials for these conditions

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