NCT07476859RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 538 (estimated)
- First submitted
- 2 Mar 2026
- Start date
- 5 Mar 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Diseases
- Coronary artery disease
- NCT number
- NCT07476859
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 538
- From 5 Mar 2026 to the primary completion date, Apr 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with intravenous or oral iron within 12 months before the index ACS.
Other illness
- 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.
Lab values
- 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.
Other
- Participation in another interventional clinical trial involving an investigational medicinal product.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Not yet recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Not yet recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.