Acute Coronary Syndromes (ACS)Phase 4HI-COR-65NCT07476859
Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
A Phase 4 study testing Ferric Carboxymaltose Injection [Ferinject] in people with Acute Coronary Syndromes (ACS) and Iron Deficiencies, run by Fundación para la Investigación del Hospital Clínico de Valencia at 9 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Coronary Syndromes (ACS), Iron Deficiencies, Elderly (People Aged 65 or More)
- What is being tested?
- Ferric Carboxymaltose Injection [Ferinject]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 9 sitesSpain
- Study dates
- 5 Mar 2026to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Spain9 sites, 9 recruiting
- Recruiting
Hospital Universitario de Badajoz
Badajoz, 06080
Javier Pérez Cervera, Doctor, +34637998882, jperezcervera@gmail.com
Javier Pérez Cervera, Doctor
- Not yet recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Pedro Luis Cepas Guillén, Doctor, +34662038836, CEPAS@clinic.cat
Pedro Luis Cepas Guillén, Doctor
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
María Asunción Esteve Pastor, Doctor, +34968381027, masunep@gmail.com
María Asunción Esteve Pastor, Doctor
- Recruiting
Hospital Universitario Clínico San Cecilio
Granada, 18016
Diego Segura-Rodríguez, Doctor, +34958023000, diegoseguracardio@gmail.com
Diego Segura-Rodríguez, Doctor
- Not yet recruiting
Hospital Universitario de León
León, 24071
Maria Thiscal López Lluva, Doctor, +34 652 684 953, mtl.lluva@gmail.com
Maria Thiscal López Lluva, Doctor
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
David Vivas Balcones, Doctor, +34658477955, dvivas@secardiologia.es
- Not yet recruiting
Hospital Universitario de Navarra
Pamplona, 31008
Gonzalo Luis Alonso Salinas, Doctor, gonzalol.alonso@gmail.com
Gonzalo Luis Alonso Salinas, Doctor
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
Clara Bonanad Lozano, Doctor, +34 686 10 70 71, clarabonanad@gmail.com
Clara Bonanad Lozano, Doctor
- Not yet recruiting
Hospital Álvaro Cunqueiro
Vigo, Pontevedra
Sergio Raposeiras Roubin, Doctor, +34886209106, raposeiras26@hotmail.com
Sergio Raposeiras Roubin, Doctor
About this study
Official title: Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome
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
Read the detailed description
Acute coronary syndrome (ACS) remains one of the leading causes of morbidity and mortality in adults aged 65 years and older. Iron deficiency is a frequent condition in this population following an ACS event and has been associated with impaired functional capacity, increased frailty, worse quality of life, and poorer clinical outcomes. While intravenous iron supplementation has demonstrated clinical benefits in patients with heart failure, its role in older patients with iron deficiency after ACS has not been systematically evaluated.
This phase IV, multicenter, open-label, randomized clinical trial has been designed to assess the impact of intravenous iron administration on quality of life and clinical outcomes in older patients with iron deficiency following ACS. The study will include patients aged 65 years or older diagnosed with ACS within the previous 15 days and presenting with iron deficiency according to current European Society of Cardiology criteria.
Eligible participants will be randomized in a 1:1 ratio to receive either a single intravenous dose of ferric carboxymaltose, administered according to body weight and baseline hemoglobin levels, or standard of care without intravenous iron supplementation. Randomization will be centralized and stratified by participating center. Given the nature of the intervention, the study will be conducted in an open-label fashion.
Participants will be followed for 12 months after randomization, with study visits scheduled at baseline, 6 months, and 12 months. Throughout follow-up, comprehensive clinical assessments will be performed, including evaluation of quality of life using the EQ-5D-5L questionnaire and assessment of frailty using the FRAIL scale. Clinical events such as heart failure decompensation, recurrent myocardial infarction, stroke, and all-cause mortality will be systematically recorded.
In addition, serial blood samples will be collected to analyze iron metabolism parameters and inflammatory biomarkers. Exploratory analyses will focus on the assessment of biological aging and cardiovascular risk markers, including DNA methylation of the ELOVL2 gene, telomere length, and circulating levels of Klotho and fibroblast growth factor 23 (FGF23). These analyses aim to provide mechanistic insights into the potential effects of iron repletion on biological aging and cardiovascular risk in this vulnerable population.
The overall duration of the study is two years, including a one-year recruitment period and a one-year follow-up period. The trial is sponsored by INCLIVA - Health Research Institute and conducted across multiple centers in Spain. The results of this study are expected to provide robust clinical evidence to support optimized management of iron deficiency in older patients following ACS, with the potential to inform future clinical guidelines and improve patient-centered outcomes.
- Being tested
- Ferric Carboxymaltose Injection [Ferinject]
- 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
- Medical subject headings
- Acute Coronary Syndrome, Iron Deficiencies, Myocardial Infarction, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Intravenous iron administered according to protocol and SmPC. Receives: Drug: Ferric Carboxymaltose Injection [Ferinject] |
| Control arm | No intervention | No specific intervention for iron deficiency (standard of care post-acute coronary syndrome) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change from baseline in frailty status assessed using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale. The FRAIL scale classifies participants as robust, pre-frail, or frail based on questionnaire responses.
Measured: Baseline, Month 6 and Month 12.
Incidence of heart failure hospitalization
Occurrence of hospitalizations due to decompensated heart failure during follow-up.
Measured: Up to 12 months
Incidence of recurrent myocardial infarction
Occurrence of non-fatal myocardial infarction during follow-up.
Measured: Up to 12 months
Incidence of stroke
Occurrence of ischemic or hemorrhagic stroke during follow-up.
Measured: Up to 12 months
All-cause mortality
Death from any cause during the 12-month follow-up period.
Measured: Up to 12 months
Change in C-reactive protein levels (inflammatory marker)
Change from baseline in C-reactive protein (CRP) levels. Units: mg/dl
Measured: Baseline and 12 months follow-up
Change in high-sensitivity C-reactive protein levels (inflammatory marker)
Change from baseline in high-sensitivity C-reactive protein (CRP) levels. Units: mg/L
Measured: Baseline and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start5 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (ratio 1:1) open-label study. Intervention with intravenous iron versus No specific intervention (standard of care) according to protocol.
- Masking
- None (open label)
- Enrolment
- 538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476859
- Sponsor's protocol ID
- HI-COR-65
- Acronym
- HI-COR-65
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07476859
- Acronym / sponsor ID
- HI-COR-65 / HI-COR-65
- Keywords
- Acute coronary syndrome, Iron deficiency, Intravenous iron, Ferric carboxymaltose, Quality of life, Older adults, Myocardial infarction, Frailty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Acute coronary syndrome (ACS) remains one of the leading causes of morbidity and mortality in adults aged 65 years and older. Iron deficiency is a frequent condition in this population following an ACS event and has been associated with impaired functional capacity, increased frailty, worse quality of life, and poorer clinical outcomes. While intravenous iron supplementation has demonstrated clinical benefits in patients with heart failure, its role in older patients with iron deficiency after ACS has not been systematically evaluated.
This phase IV, multicenter, open-label, randomized clinical trial has been designed to assess the impact of intravenous iron administration on quality of life and clinical outcomes in older patients with iron deficiency following ACS. The study will include patients aged 65 years or older diagnosed with ACS within the previous 15 days and presenting with iron deficiency according to current European Society of Cardiology criteria.
Eligible participants will be randomized in a 1:1 ratio to receive either a single intravenous dose of ferric carboxymaltose, administered according to body weight and baseline hemoglobin levels, or standard of care without intravenous iron supplementation. Randomization will be centralized and stratified by participating center. Given the nature of the intervention, the study will be conducted in an open-label fashion.
Participants will be followed for 12 months after randomization, with study visits scheduled at baseline, 6 months, and 12 months. Throughout follow-up, comprehensive clinical assessments will be performed, including evaluation of quality of life using the EQ-5D-5L questionnaire and assessment of frailty using the FRAIL scale. Clinical events such as heart failure decompensation, recurrent myocardial infarction, stroke, and all-cause mortality will be systematically recorded.
In addition, serial blood samples will be collected to analyze iron metabolism parameters and inflammatory biomarkers. Exploratory analyses will focus on the assessment of biological aging and cardiovascular risk markers, including DNA methylation of the ELOVL2 gene, telomere length, and circulating levels of Klotho and fibroblast growth factor 23 (FGF23). These analyses aim to provide mechanistic insights into the potential effects of iron repletion on biological aging and cardiovascular risk in this vulnerable population.
The overall duration of the study is two years, including a one-year recruitment period and a one-year follow-up period. The trial is sponsored by INCLIVA - Health Research Institute and conducted across multiple centers in Spain. The results of this study are expected to provide robust clinical evidence to support optimized management of iron deficiency in older patients following ACS, with the potential to inform future clinical guidelines and improve patient-centered outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized (ratio 1:1) open-label study. Intervention with intravenous iron versus No specific intervention (standard of care) according to protocol.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: Ferric Carboxymaltose Injection [Ferinject]Intravenous iron administered according to protocol and SmPC. |
| Control arm | No intervention | –No specific intervention for iron deficiency (standard of care post-acute coronary syndrome) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose Injection [Ferinject]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. | Drug | Intervention arm |
Primary outcome
Change from baseline in health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score
Time frame: Baseline, Month 6 and Month 12.
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.
7 secondary outcomes
Change from baseline in frailty status assessed using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale
Time frame: Baseline, Month 6 and Month 12.
Incidence of heart failure hospitalization
Time frame: Up to 12 months
Incidence of recurrent myocardial infarction
Time frame: Up to 12 months
Incidence of stroke
Time frame: Up to 12 months
All-cause mortality
Time frame: Up to 12 months
Change in C-reactive protein levels (inflammatory marker)
Time frame: Baseline and 12 months follow-up
Change in high-sensitivity C-reactive protein levels (inflammatory marker)
Time frame: Baseline and 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Carboxymaltose Injection [Ferinject] in people with Acute Coronary Syndromes (ACS) and Iron Deficiencies, run by Fundación para la Investigación del Hospital Clínico de Valencia at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara Bonanad Lozano, Doctor (+34 686 10 70 71, clarabonanad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score (time frame: Baseline, Month 6 and Month 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.