RecruitingPhase 4NCT07476859

Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome

Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Enrollment

538 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

Elderly (People Aged 65 or More)Iron Deficiencies acute coronary syndromes (ACS)

Summary

The goal of this phase IV, open-label, randomized clinical trial is to evaluate whether intravenous iron improves quality of life in adults aged 65 years and older with iron deficiency after an acute coronary syndrome (ACS). The main questions it aims to answer are: * Does intravenous iron improve quality of life at 6 and 12 months? * Does it reduce frailty and adverse clinical outcomes? Researchers will compare intravenous ferric carboxymaltose with standard of care. Participants will: * Be randomly assigned to receive intravenous iron or standard care * Attend three study visits over 12 months * Complete questionnaires and undergo blood tests

Eligibility

Min Age: 65 Years

Inclusion Criteria6

Age ≥ 65 years.
Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment.
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%.
Ability to provide written informed consent prior to participation.

Exclusion Criteria11

Active malignancy.
End-stage or terminal illness as determined by the IDC-Pal score.
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.
Chronic dialysis or advanced renal or hepatic failure.
Severe anemia (hemoglobin < 10 g/dL) at the time of ACS or within 15 days after the event.
Prior treatment with intravenous or oral iron within 12 months before the index ACS.
Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation.
Evidence of iron overload or disorders of iron metabolism.
Ongoing bacteremia or active systemic infection.
Participation in another interventional clinical trial involving an investigational medicinal product.
Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.

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Interventions

DRUGFerric Carboxymaltose Injection [Ferinject]

Intervention Description (Treatment Arm) Single intravenous administration of ferric carboxymaltose (Ferinject®) given at baseline within 15 days after the index acute coronary syndrome. The total iron dose is individually calculated according to body weight and hemoglobin levels, in accordance with the approved Summary of Product Characteristics (maximum 15 mg/kg, not exceeding 2,000 mg). The drug is administered in a monitored hospital setting. No additional iron doses are planned during follow-up. Intervention Description (Control Arm) Standard post-acute coronary syndrome care without specific treatment for iron deficiency. No intravenous or oral iron supplementation is administered per protocol.