NCT07476859

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

Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 538 (estimated)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Acute Coronary Syndromes (ACS)
• Iron Deficiencies
• Elderly (People Aged 65 or More)

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2026-03-05
• Primary completion: 2028-04-01
• Completion: 2028-05-01
• First posted: 2026-03-17
• Last updated: 2026-03-24

Locations

9 sites across 1 country: Spain