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O estudo clínico NCT07476859 (HI-COR-65) para Acute Coronary Syndromes (ACS), Deficiências de ferro, Elderly (People Aged 65 or More) está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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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 Randomizado Estudo aberto
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O estudo clínico NCT07476859 (HI-COR-65) procura avaliar tratamento para Acute Coronary Syndromes (ACS), Deficiências de ferro, Elderly (People Aged 65 or More). Este é um estudo intervencionista de Fase IV. Seu status atual é: em recrutamento. O estudo começou em 5 de março de 2026 e pretende incluir 538 participantes. Coordenado por Fundación para la Investigación del Hospital Clínico de Valencia e deve ser concluído em 1 de maio de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 24 de março de 2026.
Resumo
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 maisDescrição detalhada
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 mais
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
Condições médicas
Acute Coronary Syndromes (ACS)Deficiências de ferroElderly (People Aged 65 or More)Outros IDs do estudo
- HI-COR-65
Número NCT
Data de início (real)
2026-03-05
Última atualização postada
2026-03-24
Data de conclusão (estimada)
2028-05
Inscrição (estimada)
538
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Em recrutamento
Palavras-chave
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
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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 mais |
Nenhuma intervençãoControl arm No specific intervention for iron deficiency (standard of care post-acute coronary syndrome) | N/A |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Idoso
Idade mínima
65 Years
Sexos elegíveis
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 ValenciaAstraZenecaContato central do estudo
Contato: Clara Bonanad Lozano, Doctor, +34 686 10 70 71, [email protected]
Contato: Claudio Rivadulla Varela, Doctor, +34 625 11 46 86, [email protected]
9 Locais do estudo em 1 países
Murcia
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, 30120, Spain
María Asunción Esteve Pastor, Doctor, Contato, +34968381027, [email protected]
María Asunción Esteve Pastor, Doctor, Investigador principal
Em recrutamento
Pontevedra
Hospital Álvaro Cunqueiro, Vigo, Pontevedra, Spain
Sergio Raposeiras Roubin, Doctor, Contato, +34886209106, [email protected]
Sergio Raposeiras Roubin, Doctor, Investigador principal
Ainda não recrutando
Hospital Universitario de Badajoz, Badajoz, 06080, Spain
Javier Pérez Cervera, Doctor, Contato, +34637998882, [email protected]
Javier Pérez Cervera, Doctor, Investigador principal
Em recrutamento
Hospital Clínic de Barcelona, Barcelona, 08036, Spain
Pedro Luis Cepas Guillén, Doctor, Contato, +34662038836, [email protected]
Pedro Luis Cepas Guillén, Doctor, Investigador principal
Ainda não recrutando
Hospital Universitario Clínico San Cecilio, Granada, 18016, Spain
Diego Segura-Rodríguez, Doctor, Contato, +34958023000, [email protected]
Diego Segura-Rodríguez, Doctor, Investigador principal
Em recrutamento
Hospital Universitario de León, León, 24071, Spain
Maria Thiscal López Lluva, Doctor, Contato, +34 652 684 953, [email protected]
Maria Thiscal López Lluva, Doctor, Investigador principal
Ainda não recrutando
Hospital Clínico San Carlos, Madrid, 28040, Spain
David Vivas Balcones, Doctor, Contato, +34658477955, [email protected]
Em recrutamento
Hospital Universitario de Navarra, Pamplona, 31008, Spain
Gonzalo Luis Alonso Salinas, Doctor, Contato, [email protected]
Gonzalo Luis Alonso Salinas, Doctor, Investigador principal
Ainda não recrutando
Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain
Clara Bonanad Lozano, Doctor, Contato, +34 686 10 70 71, [email protected]
Clara Bonanad Lozano, Doctor, Investigador principal
Claudio Rivadulla Varela, Doctor, Subinvestigador
Em recrutamento