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 range65 Years
SexALL
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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.
✕. 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.
✕
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 ClÃnico de Valencia