Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome (NCT07476859) | Clinical Trial Compass
RecruitingPhase 4
Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
Spain538 participantsStarted 2026-03-05
Plain-language 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
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Ability to provide written informed consent prior to participation.
Exclusion criteria
. Active malignancy.
. End-stage or terminal illness as determined by the IDC-Pal score.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score
Timeframe: Baseline, Month 6 and Month 12.
Trial details
NCT IDNCT07476859
SponsorFundación para la Investigación del Hospital Clínico de Valencia
. 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.
. Chronic dialysis or advanced renal or hepatic failure.
. Severe anemia (hemoglobin \< 10 g/dL) at the time of ACS or within 15 days after the event.
. Prior treatment with intravenous or oral iron within 12 months before the index ACS.
. Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation.
. Evidence of iron overload or disorders of iron metabolism.