Intravenous iron to improve quality of life in older adults after acute coronary syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IV, multicenter, open-label randomized trial will assign patients aged 65 or older with iron deficiency after an ACS to either a single weight- and hemoglobin-adjusted dose of ferric carboxymaltose or to standard care without IV iron. Randomization is centralized and stratified by center, and participants will attend three study visits over 12 months with questionnaires, blood tests, and clinical follow-up. The primary outcome is change in quality of life at 6 and 12 months, with secondary outcomes including frailty measures and adverse cardiovascular events. Eligible patients must have had ACS within 15 days and meet iron deficiency criteria (ferritin <100 ng/mL or TSAT <20%).

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Clínico Universitario Virgen de la Arrixaca
  El Palmar, Murcia, Spain Recruiting
• Hospital Universitario de Badajoz
  Badajoz, Spain Recruiting
• Hospital Universitario Clínico San Cecilio
  Granada, Spain Recruiting
• Hospital Clínico San Carlos
  Madrid, Spain Recruiting
• Hospital Clínico Universitario de Valencia
  Valencia, Spain Recruiting
• Hospital Álvaro Cunqueiro
  Vigo, Pontevedra, Spain Not yet recruiting

Study contacts

• Study coordinator: Clara Bonanad Lozano, Doctor
• Email: clarabonanad@gmail.com
• Phone: +34 686 10 70 71

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.