Effect of intravenous iron on quality of life in older adults with acute coronary syndrome: a phase IV clinical study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

27 Feb 2026 → ongoing

Decision date (initial)

2025-12-03

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Premio Jóvenes Investigadores FAZ (VIII) y fondos del Grupo Investigación Cardiopatía Isquémica

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To determine whether patients aged 65 years or older, diagnosed with iron deficiency after an acute coronary syndrome (ACS), who receive intravenous iron treatment have a better quality of life at 6 and 12 months of follow-up compared to patients who do not receive treatment.

Secondary objectives 5

1. To evaluate the impact of iron deficiency correction on frailty, risk of heart failure decompensation, reinfarction, stroke, and all-cause mortality independently in all study patients at baseline, 6 months, and 12 months of follow-up.
2. To assess whether the extended iron profile and inflammatory mediators differ in a subgroup of treated and untreated patients at 12 months of follow-up compared to baseline levels.
3. To compare the variation in biological age in a subgroup of patients with and without intravenous iron treatment at 12 months of follow-up.
4. To assess whether telomere shortening differs in a subgroup of patients with and without intravenous iron treatment at 12 months of follow-up compared to baseline results.
5. To analyze the correlation between baseline levels of Klotho and FGF23 with biological age, telomere length, and inflammatory profile in a subgroup of patients with and without intravenous iron treatment at baseline and at 12 months of follow-up.

Conditions and MedDRA coding

Acute coronary syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients aged 65 years or older.
2. Patients with a confirmed diagnosis of acute coronary syndrome (ACS) within a maximum of 15 days prior to inclusion.
3. Patients with a confirmed diagnosis of iron deficiency at the time of hospital admission or within 15 days after the cardiac event, untreated, and defined by: - Serum ferritin <100 ng/mL, or - Transferrin saturation (TSAT) <20%, according to the European Society of Cardiology guidelines and the SEC_SEMI consensus.
4. Ability to understand the study details and to provide written informed consent prior to any trial-related procedures.

Exclusion criteria 12

1. Patients with active cancer.
2. Terminally ill patients as determined by the IDC-Pal score (Instrument for Diagnosing Complexity in Palliative Care).
3. Patients with a prior diagnosis of heart failure (HF) with a left ventricular ejection fraction (LVEF) <40%, or who develop this condition during hospitalization or within 15 days following the acute coronary syndrome (ACS) event will be excluded.
4. Patients undergoing dialysis, or with advanced hepatic or renal failure.
5. Patients with severe anemia (hemoglobin <10 g/dL) at the time of the event or within the subsequent 15 days.
6. Patients with previously diagnosed iron deficiency, identified and treated with intravenous or oral iron within the year prior to the event.
7. Patients with known hypersensitivity to intravenous iron or to any of the excipients in the product.
8. Patients with known severe hypersensitivity to other parenteral iron products.
9. Evidence of iron overload or disorders in iron utilization.
10. Patients with ongoing bacteremia.
11. Patients currently participating in other clinical trials involving investigational medicinal products.
12. Patients who, in the opinion of the investigator, should not participate in the study due to difficulties in complying with procedures, restrictions, or requirements.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in EQ-5D-5L score at 6 and 12 months vs. baseline (IV iron group vs. control).

Secondary endpoints 11

1. Change in FRAIL Scale score at 6 and 12 months vs. baseline.
2. Change in CRP and hs-CRP levels from baseline to 12 months.
3. Incidence of decompensated heart failure requiring hospitalization (12 months).
4. Incidence of non-fatal myocardial infarction (1 year).
5. Incidence of stroke (1 year).
6. All-cause mortality at 12 months.
7. Change in iron metabolism markers (iron, ferritin, serum ferritin, sTfR, TSAT, HIF-1, hepcidin) from baseline to 12 months (subgroup).
8. Change in inflammatory markers (CRP, hs-CRP, IL-1, IL-6, IL-10, IL-18, TNF-α) from baseline to 12 months (subgroup).
9. Change in biological age markers from baseline to 12 months (subgroup).
10. Change in telomere length from baseline to 12 months (subgroup).
11. Correlation of baseline Klotho and FGF23 values with adverse clinical events (HF decompensation, reinfarction, stroke, all-cause mortality) at 12 months (subgroup).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Sponsor organisation

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Address

Avenida Menendez Y Pelayo 4

City

Valencia

Postcode

46010

Country

Spain

Scientific contact point

Organisation

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Contact name

Clara Bonanad Lozano

Public contact point

Organisation

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Contact name

Unidad de Investigación Clínica y Ensayos Clínicos (UICEC-INCLIVA)

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications