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One-Time iron infusion could boost recovery in elderly heart patients

NCT ID NCT07476859

Symptom relief Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a single intravenous dose of iron can improve quality of life and reduce frailty in adults aged 65 and older who have iron deficiency after a heart attack. About 538 participants will be randomly assigned to receive either the iron infusion or standard care, and they will be followed for 12 months with questionnaires and blood tests. The goal is to see if correcting iron deficiency helps patients feel better and recover more fully.

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)
What this could lead to
If it works, this could offer a simple, one-time treatment to help older adults feel better and be less frail after a heart attack.
What could go wrong
This is a phase 4 trial, but iron therapy may not improve quality of life significantly, and some people may have side effects like allergic reactions or low blood pressure.

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 538 people

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

Started

Mar 2026

Expected to finish

May 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: 1. Age ≥ 65 years. 2. Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment. 3. Iron deficiency diagnosed at admission or within 15 days after the index ACS event, defined as: * Serum ferritin \< 100 ng/mL, OR * Transferrin saturation (TSAT) \< 20%. 4. Ability to provide written informed consent prior to participation. Exclusion Criteria: 1. Active malignancy. 2. End-stage or terminal illness as determined by the IDC-Pal score. 3. Known heart failure with left ventricular ejection fraction (LVEF) \< 40% prior to enrollment, or development of LVEF \< 40% during hospitalization or within 15 days after ACS. 4. Chronic dialysis or advanced renal or hepatic failure. 5. Severe anemia (hemoglobin \< 10 g/dL) at the time of ACS or within 15 days after the event. 6. Prior treatment with intravenous or oral iron within 12 months before the index ACS. 7. Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation. 8. Evidence of iron overload or disorders of iron metabolism. 9. Ongoing bacteremia or active systemic infection. 10. Participation in another interventional clinical trial involving an investigational medicinal product. 11. Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome Frailty Iron Deficiencies myocardial infarction

As listed by the trial registrant

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

Acute coronary syndromes (ACS) Elderly (people aged 65 or more) Iron deficiencies

How to take part

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

  1. The places running it

    9 sites. 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

  • Hospital Clínic de Barcelona

    NOT_YET_RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitario Clínico San Cecilio

    RECRUITING

    Granada, 18016, Spain

  • Hospital Universitario de Badajoz

    RECRUITING

    Badajoz, 06080, Spain

  • Hospital Universitario de León

    NOT_YET_RECRUITING

    León, 24071, Spain

  • Hospital Universitario de Navarra

    NOT_YET_RECRUITING

    Pamplona, 31008, Spain

  • Hospital Álvaro Cunqueiro

    NOT_YET_RECRUITING

    Vigo, Pontevedra, Spain

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