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
Age ≥ 65 years.
Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment.
Serum ferritin < 100 ng/mL, OR
Transferrin saturation (TSAT) < 20%.
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.
Fundación para la Investigación del Hospital Clínico de Valencia
Lead sponsor
AstraZeneca
Collaborator