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El ensayo clínico NCT07476859 (HI-COR-65) para Acute Coronary Syndromes (ACS), Deficiencias de hierro, Elderly (People Aged 65 or More) está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome (HI-COR-65) Fase IV 538 Aleatorizado Etiqueta abierta
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El ensayo clínico NCT07476859 (HI-COR-65) está diseñado para estudiar el tratamiento de Acute Coronary Syndromes (ACS), Deficiencias de hierro, Elderly (People Aged 65 or More). Es un estudio intervencionista de Fase IV. Su estado actual es: reclutando. El estudio se inició el 5 de marzo de 2026, con el objetivo de reclutar a 538 participantes. Dirigido por Fundación para la Investigación del Hospital Clínico de Valencia, se espera que finalice el 1 de mayo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 24 de marzo de 2026.
Resumen
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 i...
Mostrar másDescripción detallada
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 pati...Mostrar más
Título oficial
Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome
Condiciones médicas
Acute Coronary Syndromes (ACS)Deficiencias de hierroElderly (People Aged 65 or More)Otros ID del estudio
- HI-COR-65
Número del NCT
Inicio del estudio (real)
2026-03-05
Última actualización
2026-03-24
Fecha de finalización (estimada)
2028-05
Inscripción (prevista)
538
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Reclutando
Palabras clave
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
Iron deficiency
Intravenous iron
Ferric carboxymaltose
Quality of life
Older adults
Myocardial infarction
Frailty
Cardiovascular outcomes
Biological aging
ELOVL2 methylation
Telomere length
Klotho
FGF23
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalIntervention arm Intravenous iron administered according to protocol and SmPC. | 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 i...Mostrar más |
Sin intervenciónControl arm No specific intervention for iron deficiency (standard of care post-acute coronary syndrome) | N/A |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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. | Baseline, Month 6 and Month 12. |
Incidence of heart failure hospitalization | Occurrence of hospitalizations due to decompensated heart failure during follow-up. | Up to 12 months |
Incidence of recurrent myocardial infarction | Occurrence of non-fatal myocardial infarction during follow-up. | Up to 12 months |
Incidence of stroke | Occurrence of ischemic or hemorrhagic stroke during follow-up. | Up to 12 months |
All-cause mortality | Death from any cause during the 12-month follow-up period. | Up to 12 months |
Change in C-reactive protein levels (inflammatory marker) | Change from baseline in C-reactive protein (CRP) levels. Units: mg/dl | 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 | Baseline and 12 months follow-up |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto mayor
Edad mínima
65 Years
Criterios de sexo
Todos
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.
- 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.
Fundación para la Investigación del Hospital Clínico de ValenciaAstraZenecaContactos centrales del estudio
Contacto: Clara Bonanad Lozano, Doctor, +34 686 10 70 71, [email protected]
Contacto: Claudio Rivadulla Varela, Doctor, +34 625 11 46 86, [email protected]
9 Centros del estudio en 1 países
Murcia
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, 30120, Spain
María Asunción Esteve Pastor, Doctor, Contacto, +34968381027, [email protected]
María Asunción Esteve Pastor, Doctor, Investigador principal
Reclutando
Pontevedra
Hospital Álvaro Cunqueiro, Vigo, Pontevedra, Spain
Sergio Raposeiras Roubin, Doctor, Contacto, +34886209106, [email protected]
Sergio Raposeiras Roubin, Doctor, Investigador principal
Aún no recluta
Hospital Universitario de Badajoz, Badajoz, 06080, Spain
Javier Pérez Cervera, Doctor, Contacto, +34637998882, [email protected]
Javier Pérez Cervera, Doctor, Investigador principal
Reclutando
Hospital Clínic de Barcelona, Barcelona, 08036, Spain
Pedro Luis Cepas Guillén, Doctor, Contacto, +34662038836, [email protected]
Pedro Luis Cepas Guillén, Doctor, Investigador principal
Aún no recluta
Hospital Universitario Clínico San Cecilio, Granada, 18016, Spain
Diego Segura-Rodríguez, Doctor, Contacto, +34958023000, [email protected]
Diego Segura-Rodríguez, Doctor, Investigador principal
Reclutando
Hospital Universitario de León, León, 24071, Spain
Maria Thiscal López Lluva, Doctor, Contacto, +34 652 684 953, [email protected]
Maria Thiscal López Lluva, Doctor, Investigador principal
Aún no recluta
Hospital Clínico San Carlos, Madrid, 28040, Spain
David Vivas Balcones, Doctor, Contacto, +34658477955, [email protected]
Reclutando
Hospital Universitario de Navarra, Pamplona, 31008, Spain
Gonzalo Luis Alonso Salinas, Doctor, Contacto, [email protected]
Gonzalo Luis Alonso Salinas, Doctor, Investigador principal
Aún no recluta
Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain
Clara Bonanad Lozano, Doctor, Contacto, +34 686 10 70 71, [email protected]
Clara Bonanad Lozano, Doctor, Investigador principal
Claudio Rivadulla Varela, Doctor, Subinvestigador
Reclutando