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

Acute coronary syndrome (ACS) remains one of the leading causes of morbidity and mortality in adults aged 65 years and older. Iron deficiency is a frequent condition in this population following an ACS event and has been associated with impaired functional capacity, increased frailty, worse quality of life, and poorer clinical outcomes. While intravenous iron supplementation has demonstrated clinical benefits in patients with heart failure, its role in older patients with iron deficiency after ACS has not been systematically evaluated.

This phase IV, multicenter, open-label, randomized clinical trial has been designed to assess the impact of intravenous iron administration on quality of life and clinical outcomes in older patients with iron deficiency following ACS. The study will include patients aged 65 years or older diagnosed with ACS within the previous 15 days and presenting with iron deficiency according to current European Society of Cardiology criteria.

Eligible participants will be randomized in a 1:1 ratio to receive either a single intravenous dose of ferric carboxymaltose, administered according to body weight and baseline hemoglobin levels, or standard of care without intravenous iron supplementation. Randomization will be centralized and stratified by participating center. Given the nature of the intervention, the study will be conducted in an open-label fashion.

Participants will be followed for 12 months after randomization, with study visits scheduled at baseline, 6 months, and 12 months. Throughout follow-up, comprehensive clinical assessments will be performed, including evaluation of quality of life using the EQ-5D-5L questionnaire and assessment of frailty using the FRAIL scale. Clinical events such as heart failure decompensation, recurrent myocardial infarction, stroke, and all-cause mortality will be systematically recorded.

In addition, serial blood samples will be collected to analyze iron metabolism parameters and inflammatory biomarkers. Exploratory analyses will focus on the assessment of biological aging and cardiovascular risk markers, including DNA methylation of the ELOVL2 gene, telomere length, and circulating levels of Klotho and fibroblast growth factor 23 (FGF23). These analyses aim to provide mechanistic insights into the potential effects of iron repletion on biological aging and cardiovascular risk in this vulnerable population.

The overall duration of the study is two years, including a one-year recruitment period and a one-year follow-up period. The trial is sponsored by INCLIVA - Health Research Institute and conducted across multiple centers in Spain. The results of this study are expected to provide robust clinical evidence to support optimized management of iron deficiency in older patients following ACS, with the potential to inform future clinical guidelines and improve patient-centered outcomes.

• Change from baseline in frailty status assessed using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale [Срок оценки: Baseline, Month 6 and Month 12.]
• Incidence of heart failure hospitalization [Срок оценки: Up to 12 months]
• Incidence of recurrent myocardial infarction [Срок оценки: Up to 12 months]
• Incidence of stroke [Срок оценки: Up to 12 months]
• All-cause mortality [Срок оценки: Up to 12 months]
• Change in C-reactive protein levels (inflammatory marker) [Срок оценки: Baseline and 12 months follow-up]
• Change in high-sensitivity C-reactive protein levels (inflammatory marker) [Срок оценки: Baseline and 12 months follow-up]