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Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
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
Official title: Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
538
Start Date
2026-03-05
Completion Date
2028-05
Last Updated
2026-03-24
Healthy Volunteers
No
Interventions
Ferric 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.
Locations (9)
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital Universitario de León
León, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain