Actively Recruiting
Phase IV, Open-label, Randomized Trial of Intravenous Iron on Quality of Life in Older Adults With Acute Coronary Syndrome
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2026-03-24
538
Participants Needed
9
Research Sites
4 weeks
Total Duration
On this page
Sponsors
F
Fundación para la Investigación del Hospital Clínico de Valencia
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess whether intravenous iron improves quality of life for adults aged 65 years and older who have iron deficiency following an acute coronary syndrome (ACS). It focuses on whether intravenous iron can enhance quality of life at 6 and 12 months, reduce frailty, and lower adverse clinical outcomes compared to standard care. The study is a phase IV, open-label, randomized clinical trial involving older patients recently diagnosed with ACS and iron deficiency. Participants will be randomly assigned to receive either a single intravenous dose of ferric carboxymaltose, calculated based on body weight and hemoglobin levels, or standard post-ACS care without iron supplementation. The intravenous iron is administered once within 15 days after the ACS event in a monitored hospital setting. The study includes three visits over a 12-month follow-up period to monitor and compare outcomes between the two groups. During the study, participants will complete questionnaires on quality of life using the EQ-5D-5L and frailty using the FRAIL scale at baseline, 6 months, and 12 months. Blood samples will be taken to analyze iron metabolism and inflammatory markers, along with exploratory tests related to biological aging and cardiovascular risk markers. Researchers will also track clinical events such as heart failure hospitalizations, recurrent heart attacks, strokes, and mortality. The total duration of participation is one year after enrollment, with comprehensive safety and health assessments throughout.
CONDITIONS
Brief Title
Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Hospitalized for confirmed acute coronary syndrome within 15 days before enrollment
- Diagnosed with iron deficiency at admission or within 15 days after ACS, defined as serum ferritin less than 100 ng/mL or transferrin saturation less than 20%
- Able to provide written informed consent before participation
You will not qualify if you...
- Active malignancy
- End-stage or terminal illness as determined by IDC-Pal score
- Known heart failure with left ventricular ejection fraction less than 40% before enrollment or during hospitalization/within 15 days after ACS
- Chronic dialysis or advanced kidney or liver failure
- Severe anemia with hemoglobin less than 10 g/dL at ACS or within 15 days after
- Prior intravenous or oral iron treatment within 12 months before ACS
- Known allergy to ferric carboxymaltose or related iron products
- Evidence of iron overload or iron metabolism disorders
- Ongoing bacteremia or active systemic infection
- Participation in another interventional trial with investigational drug
- Any condition compromising safety, protocol compliance, or study integrity as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 15 days before enrollment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single administration within 15 days after acute coronary syndrome
Participants are randomized to receive either a single intravenous dose of ferric carboxymaltose or standard care without iron supplementation. The intravenous iron dose is calculated based on body weight and hemoglobin levels and administered in a hospital setting.
1 visit (in-person) for treatment administration
Duration - 12 months
Participants are followed for 12 months after randomization with clinical assessments including quality of life, frailty status, and blood sample collections. Clinical events such as heart failure, myocardial infarction, stroke, and mortality are recorded.
3 visits (baseline, 6 months, and 12 months)
Trial Site Locations
Total: 9 locations
1
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
2
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Not Yet Recruiting
3
Hospital Universitario de Badajoz
Badajoz, Spain, 06080
Actively Recruiting
4
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Not Yet Recruiting
5
Hospital Universitario Clínico San Cecilio
Granada, Spain, 18016
Actively Recruiting
6
Hospital Universitario de León
León, Spain, 24071
Not Yet Recruiting
7
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
8
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Not Yet Recruiting
9
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
C
Clara Bonanad Lozano, Doctor
C
Claudio Rivadulla Varela, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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