Intravenous iron and quality of life in older adults after acute coronary syndrome
Tests intravenous iron in adults 65 and older with iron deficiency after acute coronary syndrome.
Plain-language title generated from the registry record
Registry title: Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
Key facts
- Where
- Badajoz, Barcelona, El Palmar, Granada, León, Madrid, Pamplona, Valencia, and Vigo, SpainSee the 9 sites
- Phase
- Phase 4
Where in Spain
- Hospital Universitario de BadajozBadajoz, SpainTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainNot yet recruiting
- Hospital Clínico Universitario Virgen de la ArrixacaEl Palmar, SpainTaking people
- Hospital Universitario Clínico San CecilioGranada, SpainTaking people
- Hospital Universitario De LeonLeón, SpainNot yet recruiting
- Hospital Clínico San CarlosMadrid, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainNot yet recruiting
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
- Hospital Alvaro CunqueiroVigo, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación para la Investigación del Hospital Clínico de Valencia
- Trial code
- NCT07476859
- Record updated
- 24 March 2026
- Original description
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).Read full original descriptionShow less
Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome
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
Inclusion: Age ≥ 65 years; Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment; Iron deficiency diagnosed at admission or within 15 days after the index ACS event, defined as:; Serum ferritin < 100 ng/mL, OR; Transferrin saturation (TSAT) < 20%; Ability to provide written informed consent prior to participation.
Exclusion: Prior treatment with intravenous or oral iron within 12 months before the index ACS; Active malignancy; End-stage or terminal illness as determined by the IDC-Pal score; Chronic dialysis or advanced renal or hepatic failure; Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation; Evidence of iron overload or disorders of iron metabolism; Ongoing bacteremia or active systemic infection; Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity; Known heart failure with left ventricular ejection fraction (LVEF) < 40% prior to enrollment, or development of LVEF < 40% during hospitalization or within 15 days after ACS; Severe anemia (hemoglobin < 10 g/dL) at the time of ACS or within 15 days after the event; Participation in another interventional clinical trial involving an investigational medicinal product.