Intravenous iron to improve quality of life in older adults after 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

This trial will try a single dose of intravenous ferric carboxymaltose in people 65 and older with iron deficiency after an acute coronary event to see if it improves quality of life and reduces frailty and adverse outcomes over 12 months.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 538 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia (Academic / other)
• Locations: 9 sites (El Palmar, Murcia and 8 other locations)
• Trial ID: NCT07476859 on ClinicalTrials.gov

What this trial studies

This phase IV, multicenter, open-label randomized trial will assign patients aged 65 or older with iron deficiency after an ACS to either a single weight- and hemoglobin-adjusted dose of ferric carboxymaltose or to standard care without IV iron. Randomization is centralized and stratified by center, and participants will attend three study visits over 12 months with questionnaires, blood tests, and clinical follow-up. The primary outcome is change in quality of life at 6 and 12 months, with secondary outcomes including frailty measures and adverse cardiovascular events. Eligible patients must have had ACS within 15 days and meet iron deficiency criteria (ferritin <100 ng/mL or TSAT <20%).

Who should consider this trial

Good fit: Ideal candidates are adults aged 65 or older who were hospitalized for ACS within the past 15 days, have iron deficiency (ferritin <100 ng/mL or TSAT <20%), can provide informed consent, and do not have recent IV/oral iron treatment.

Not a fit: Patients with active malignancy, end-stage illness, severe anemia (hemoglobin <10 g/dL), LVEF <40%, chronic dialysis, advanced renal or hepatic failure, or recent iron treatment are unlikely to benefit or are excluded from this approach.

Why it matters

Potential benefit: If successful, the intervention could improve quality of life, reduce frailty, and lower adverse clinical events in older patients with iron deficiency after ACS.

How similar studies have performed: Intravenous ferric carboxymaltose has improved symptoms, exercise capacity, and quality of life in heart failure trials, but its use specifically in older patients after ACS remains largely untested.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 65 years.
2. Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment.
3. 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%.
4. Ability to provide written informed consent prior to participation.

Exclusion Criteria:

1. Active malignancy.
2. End-stage or terminal illness as determined by the IDC-Pal score.
3. 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.
4. Chronic dialysis or advanced renal or hepatic failure.
5. Severe anemia (hemoglobin \< 10 g/dL) at the time of ACS or within 15 days after the event.
6. Prior treatment with intravenous or oral iron within 12 months before the index ACS.
7. Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation.
8. Evidence of iron overload or disorders of iron metabolism.
9. Ongoing bacteremia or active systemic infection.
10. Participation in another interventional clinical trial involving an investigational medicinal product.
11. Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.

Where this trial is running

El Palmar, Murcia and 8 other locations

• Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (Recruiting)
• Hospital Álvaro Cunqueiro — Vigo, Pontevedra, Spain (Not_yet_recruiting)
• Hospital Universitario de Badajoz — Badajoz, Spain (Recruiting)
• Hospital Clínic de Barcelona — Barcelona, Spain (Not_yet_recruiting)
• Hospital Universitario Clínico San Cecilio — Granada, Spain (Recruiting)
• Hospital Universitario de León — León, Spain (Not_yet_recruiting)
• Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
• Hospital Universitario de Navarra — Pamplona, Spain (Not_yet_recruiting)
• Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: Clara Bonanad Lozano, Doctor

Conditions Acute Coronary Syndromes; Iron Deficiencies; Elderly; Acute coronary syndrome; Iron deficiency; Intravenous iron; Ferric carboxymaltose; Quality of life