Phase IV Study of Intravenous Iron Treatment to Improve Quality of Life in Adults 65 and Older After Acute Coronary Syndrome

What this Trial Is About

This research aims to assess whether intravenous iron improves quality of life for adults aged 65 years and older who have iron deficiency following an acute coronary syndrome ACS. It focuses on whether intravenous iron can enhance quality of life at 6 and 12 months, reduce frailty, and lower adverse clinical outcomes compared to standard care. The study is a phase IV, open-label, randomized clinical trial involving older patients recently diagnosed with ACS and iron deficiency. Participants will be randomly assigned to receive either a single intravenous dose of ferric carboxymaltose, calculated based on body weight and hemoglobin levels, or standard post-ACS care without iron supplementation. The intravenous iron is administered once within 15 days after the ACS event in a monitored hospital setting. The study includes three visits over a 12-month follow-up period to monitor and compare outcomes between the two groups. During the study, participants will complete questionnaires on quality of life using the EQ-5D-5L and frailty using the FRAIL scale at baseline, 6 months, and 12 months. Blood samples will be taken to analyze iron metabolism and inflammatory markers, along with exploratory tests related to biological aging and cardiovascular risk markers. Researchers will also track clinical events such as heart failure hospitalizations, recurrent heart attacks, strokes, and mortality. The total duration of participation is one year after enrollment, with comprehensive safety and health assessments throughout.

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