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.
Parallel
Ferric Carboxymaltose Injection [Ferinject]
DrugIntervention 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.
Change from baseline in health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score
Change from baseline in health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L index score ranges from 0 to 1, where 0 represents the worst health state and 1 represents full health. Higher scores indicate better health-related quality of life. Scores will be evaluated at 6 and 12 months and compared with baseline between participants receiving intravenous ferric carboxymaltose and those receiving no iron treatment.
Change from baseline in frailty status assessed using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale
Change from baseline in frailty status assessed using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale. The FRAIL scale classifies participants as robust, pre-frail, or frail based on questionnaire responses.
Incidence of heart failure hospitalization
Occurrence of hospitalizations due to decompensated heart failure during follow-up.
Incidence of recurrent myocardial infarction
Occurrence of non-fatal myocardial infarction during follow-up.
Incidence of stroke
Occurrence of ischemic or hemorrhagic stroke during follow-up.
Change from baseline in serum ferritin concentration
Change from baseline in serum ferritin concentration measured in blood samples in a predefined subgroup of participants. Units: ng/mL
Change from baseline in transferrin saturation
Change from baseline in transferrin saturation (TSAT) measured in blood samples in a predefined subgroup of participants. Transferrin saturation will be reported as percentage (%).
Change from baseline in soluble transferrin receptor concentration
Change from baseline in soluble transferrin receptor (sTfR) concentration measured in blood samples in a predefined subgroup of participants. Concentrations will be reported in milligrams per liter (mg/L).
Change from baseline in serum hepcidin concentration
Change from baseline in serum hepcidin concentration measured in blood samples in a predefined subgroup of participants. Concentrations will be reported in nanograms per milliliter (ng/mL).
Click on the lead sponsor to view all of their trials.
Fundación para la Investigación del Hospital Clínico de Valencia
Lead sponsor
AstraZeneca
Collaborator
