Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome

NCT07476859 | Recruiting Phase 4

• 1 other identifier: HI-COR-65
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 9

Brief 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

Conditions

Elderly (People Aged 65 or More); Acute Coronary Syndromes (ACS); Iron Deficiencies

Keywords

Acute coronary syndrome; Iron deficiency; Intravenous iron; Ferric carboxymaltose; Quality of life; Older adults; Myocardial infarction; Frailty; Cardiovascular outcomes; Biological aging; ELOVL2 methylation; Telomere length; Klotho; FGF23

Outcome Measures

Primary Outcomes (1)

• Change from baseline in health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score

  Change from baseline in health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L index score ranges from 0 to 1, where 0 represents the worst health state and 1 represents full health. Higher scores indicate better health-related quality of life. Scores will be evaluated at 6 and 12 months and compared with baseline between participants receiving intravenous ferric carboxymaltose and those receiving no iron treatment.

  Baseline, Month 6 and Month 12.

Secondary Outcomes (7)

• Change from baseline in frailty status assessed using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale

  Baseline, Month 6 and Month 12.

• Incidence of heart failure hospitalization

  Up to 12 months

• Incidence of recurrent myocardial infarction

  Up to 12 months

• Incidence of stroke

  Up to 12 months

• All-cause mortality

  Up to 12 months

Other Outcomes (14)

• Change from baseline in serum ferritin concentration

  Baseline and 12 months

• Change from baseline in transferrin saturation

  Baseline and 12 months

• Change from baseline in soluble transferrin receptor concentration

  Baseline and 12 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intravenous iron administered according to protocol and SmPC.

Drug: Ferric Carboxymaltose Injection [Ferinject]

Control arm

NO INTERVENTION

No specific intervention for iron deficiency (standard of care post-acute coronary syndrome)

Interventions

Ferric Carboxymaltose Injection [Ferinject] DRUG

Intervention Description (Treatment Arm) Single intravenous administration of ferric carboxymaltose (Ferinject®) given at baseline within 15 days after the index acute coronary syndrome. The total iron dose is individually calculated according to body weight and hemoglobin levels, in accordance with the approved Summary of Product Characteristics (maximum 15 mg/kg, not exceeding 2,000 mg). The drug is administered in a monitored hospital setting. No additional iron doses are planned during follow-up. Intervention Description (Control Arm) Standard post-acute coronary syndrome care without specific treatment for iron deficiency. No intravenous or oral iron supplementation is administered per protocol.

Intervention arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Ongoing bacteremia or active systemic infection.
• Participation in another interventional clinical trial involving an investigational medicinal product.
• Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead
• AstraZeneca: collaborator

Study Sites (9)

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

NOT YET RECRUITING

Hospital Universitario de Badajoz

Badajoz, 06080, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

NOT YET RECRUITING

Hospital Universitario Clínico San Cecilio

Granada, 18016, Spain

RECRUITING

Hospital Universitario de León

León, 24071, Spain

NOT YET RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, 31008, Spain

NOT YET RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Iron Deficiencies; Myocardial Infarction; Frailty

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Clara Bonanad Lozano, Doctor

CONTACT

+34 686 10 70 71; clarabonanad@gmail.com

Claudio Rivadulla Varela, Doctor

CONTACT

+34 625 11 46 86; c.rivare@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized (ratio 1:1) open-label study. Intervention with intravenous iron versus No specific intervention (standard of care) according to protocol.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 17, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

ES (9)