Effect of intravenous iron on quality of life in older adults with acute coronary syndrome: a phase IV clinical study

Introduction

Acute coronary syndrome (ACS) is the leading cause of mortality in developed countries, particularly in the older population. Iron deficiency is a frequent comorbidity after ACS, with a prevalence close to 60%, and is associated with poorer prognosis, a higher risk of heart failure, and increased mortality. Although intravenous iron therapy has demonstrated clinical and quality-of-life benefits in patients with heart failure, its impact on older patients after ACS has not been specifically evaluated.

Objective

To assess whether correction of iron deficiency with intravenous iron improves quality of life in patients aged 65 years or older after ACS, compared with standard care without specific treatment for iron deficiency.

Methods

Phase IV, open-label, randomized, multicenter, national clinical trial. Patients aged ≥65 years with a recent diagnosis of ACS (≤15 days) and untreated iron deficiency will be included. Participants will be randomized 1:1 to receive a single dose of intravenous ferric carboxymaltose or to a control group without treatment. The primary outcome is the change in quality of life measured using the EQ-5D-5L questionnaire at 6 and 12 months. Secondary outcomes will include frailty (FRAIL scale), systemic inflammation, major adverse cardiovascular events—specifically rehospitalizations or decompensations due to heart failure—mortality, and, in a subgroup, biomarkers of aging, biological age, and telomere length.

Expected results:

Correction of iron deficiency with intravenous iron is expected to be associated with a significant improvement in quality of life, as well as a reduction in frailty and adverse clinical events, particularly hospitalizations or decompensations due to heart failure during follow-up.

Conclusions

The HI-COR-65 study will provide relevant clinical evidence on the impact of treating iron deficiency in older patients after ACS, integrating a holistic approach that combines quality of life, clinical prognosis, and aging biomarkers, with potential implications for future therapeutic recommendations.