Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:09 AM
Study NCT ID:
NCT07476859
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized (ratio 1:1) open-label study. Intervention with intravenous iron versus No specific intervention (standard of care) according to protocol.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 538}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in serum ferritin concentration', 'timeFrame': 'Baseline and 12 months', 'description': 'Change from baseline in serum ferritin concentration measured in blood samples in a predefined subgroup of participants. Units: ng/mL'}, {'measure': 'Change from baseline in transferrin saturation', 'timeFrame': 'Baseline and 12 months', 'description': 'Change from baseline in transferrin saturation (TSAT) measured in blood samples in a predefined subgroup of participants.\n\nTransferrin saturation will be reported as percentage (%).'}, {'measure': 'Change from baseline in soluble transferrin receptor concentration', 'timeFrame': 'Baseline and 12 months', 'description': 'Change from baseline in soluble transferrin receptor (sTfR) concentration measured in blood samples in a predefined subgroup of participants.\n\nConcentrations will be reported in milligrams per liter (mg/L).'}, {'measure': 'Change from baseline in serum hepcidin concentration', 'timeFrame': 'Baseline and 12 months', 'description': 'Change from baseline in serum hepcidin concentration measured in blood samples in a predefined subgroup of participants.\n\nConcentrations will be reported in nanograms per milliliter (ng/mL).'}, {'measure': 'Change from baseline in hypoxia-inducible factor 1 (HIF-1) levels', 'timeFrame': 'Baseline and 12 months', 'description': 'Change from baseline in hypoxia-inducible factor 1 (HIF-1) levels measured in blood samples in a predefined subgroup of participants.\n\nValues will be reported in ng/ul.'}, {'measure': 'Change from baseline in interleukin-1 concentration', 'timeFrame': 'Baseline and at 12 months follow-up', 'description': 'Change from baseline in interleukin-1 (IL-1) concentration measured in blood samples in a predefined subgroup of participants.\n\nValues will be reported in nanograms per microliter (ng/µL).'}, {'measure': 'Change from baseline in interleukin-6 concentration', 'timeFrame': 'Baseline and at 12 months follow-up', 'description': 'Change from baseline in interleukin-6 (IL-6) concentration measured in blood samples in a predefined subgroup of participants.\n\nValues will be reported in nanograms per microliter (ng/µL).'}, {'measure': 'Change from baseline in interleukin-10 concentration', 'timeFrame': 'Baseline and at 12 months follow-up', 'description': 'Change from baseline in interleukin-10 (IL-10) concentration measured in blood samples in a predefined subgroup of participants.\n\nValues will be reported in nanograms per microliter (ng/µL).'}, {'measure': 'Change from baseline in interleukin-18 concentration', 'timeFrame': 'Baseline and at 12 months follow-up', 'description': 'Change from baseline in interleukin-18 (IL-18) concentration measured in blood samples in a predefined subgroup of participants.\n\nValues will be reported in nanograms per microliter (ng/µL).'}, {'measure': 'Change from baseline in tumor necrosis factor alpha concentration', 'timeFrame': 'Baseline and at 12 months follow-up', 'description': 'Change from baseline in tumor necrosis factor alpha (TNF-α) concentration measured in blood samples in a predefined subgroup of participants.\n\nValues will be reported in nanograms per microliter (ng/µL).'}, {'measure': 'Change from baseline in epigenetic age acceleration measured by ELOVL2 DNA methylation', 'timeFrame': 'Baseline and at 12 months follow-up', 'description': 'Change from baseline in epigenetic age acceleration assessed using DNA methylation of the ELOVL2 gene in blood samples from a predefined subgroup of participants. Epigenetic age acceleration will be reported in years of biological age.'}, {'measure': 'Change from baseline in telomere length', 'timeFrame': 'Baseline and at 12 months follow-up', 'description': 'Change from baseline in telomere length measured using the telomere-to-single copy gene (T/S) ratio in blood samples from a predefined subgroup of participants.'}, {'measure': 'Association between baseline Klotho concentration and occurrence of major adverse cardiovascular events.', 'timeFrame': 'Baseline and through Month 12 follow-up.', 'description': 'Association between baseline Klotho concentration measured in blood samples and the occurrence of major adverse cardiovascular events (MACE) during follow-up in a predefined subgroup of participants. Klotho concentrations will be reported in nanograms per microliter (ng/µL).'}, {'measure': 'Association between baseline fibroblast growth factor 23 concentration and occurrence of major adverse cardiovascular events.', 'timeFrame': 'Baseline and through Month 12 follow-up.', 'description': 'Association between baseline fibroblast growth factor 23 (FGF23) concentration measured in blood samples and the occurrence of major adverse cardiovascular events (MACE) during follow-up in a predefined subgroup of participants. Concentrations will be reported in nanograms per microliter (ng/µL).'}], 'primaryOutcomes': [{'measure': 'Change from baseline in health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score', 'timeFrame': 'Baseline, Month 6 and Month 12.', 'description': 'Change from baseline in health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).\n\nThe EQ-5D-5L index score ranges from 0 to 1, where 0 represents the worst health state and 1 represents full health.\n\nHigher 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.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in frailty status assessed using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale', 'timeFrame': 'Baseline, Month 6 and Month 12.', 'description': '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.'}, {'measure': 'Incidence of heart failure hospitalization', 'timeFrame': 'Up to 12 months', 'description': 'Occurrence of hospitalizations due to decompensated heart failure during follow-up.'}, {'measure': 'Incidence of recurrent myocardial infarction', 'timeFrame': 'Up to 12 months', 'description': 'Occurrence of non-fatal myocardial infarction during follow-up.'}, {'measure': 'Incidence of stroke', 'timeFrame': 'Up to 12 months', 'description': 'Occurrence of ischemic or hemorrhagic stroke during follow-up.'}, {'measure': 'All-cause mortality', 'timeFrame': 'Up to 12 months', 'description': 'Death from any cause during the 12-month follow-up period.'}, {'measure': 'Change in C-reactive protein levels (inflammatory marker)', 'timeFrame': 'Baseline and 12 months follow-up', 'description': 'Change from baseline in C-reactive protein (CRP) levels. Units: mg/dl'}, {'measure': 'Change in high-sensitivity C-reactive protein levels (inflammatory marker)', 'timeFrame': 'Baseline and 12 months follow-up', 'description': 'Change from baseline in high-sensitivity C-reactive protein (CRP) levels. Units: mg/L'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Acute Coronary Syndromes (ACS)', 'Iron Deficiencies', 'Elderly (People Aged 65 or More)']}, 'descriptionModule': {'briefSummary': '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).\n\nThe main questions it aims to answer are:\n\n* Does intravenous iron improve quality of life at 6 and 12 months?\n* Does it reduce frailty and adverse clinical outcomes?\n\nResearchers will compare intravenous ferric carboxymaltose with standard of care.\n\nParticipants will:\n\n* Be randomly assigned to receive intravenous iron or standard care\n* Attend three study visits over 12 months\n* Complete questionnaires and undergo blood tests', 'detailedDescription': '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.\n\nThis 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.\n\nEligible 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.\n\nParticipants 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.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 65 years.\n2. Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment.\n3. Iron deficiency diagnosed at admission or within 15 days after the index ACS event, defined as:\n\n * Serum ferritin \\< 100 ng/mL, OR\n * Transferrin saturation (TSAT) \\< 20%.\n4. Ability to provide written informed consent prior to participation.\n\nExclusion Criteria:\n\n1. Active malignancy.\n2. End-stage or terminal illness as determined by the IDC-Pal score.\n3. 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.\n4. Chronic dialysis or advanced renal or hepatic failure.\n5. Severe anemia (hemoglobin \\< 10 g/dL) at the time of ACS or within 15 days after the event.\n6. Prior treatment with intravenous or oral iron within 12 months before the index ACS.\n7. Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation.\n8. Evidence of iron overload or disorders of iron metabolism.\n9. Ongoing bacteremia or active systemic infection.\n10. Participation in another interventional clinical trial involving an investigational medicinal product.\n11. Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity."}, 'identificationModule': {'nctId': 'NCT07476859', 'acronym': 'HI-COR-65', 'briefTitle': 'Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Investigación del Hospital Clínico de Valencia'}, 'officialTitle': 'Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'HI-COR-65'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Intravenous iron administered according to protocol and SmPC.', 'interventionNames': ['Drug: Ferric Carboxymaltose Injection [Ferinject]']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'No specific intervention for iron deficiency (standard of care post-acute coronary syndrome)'}], 'interventions': [{'name': 'Ferric Carboxymaltose Injection [Ferinject]', 'type': 'DRUG', 'description': 'Intervention Description (Treatment Arm)\n\nSingle 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.\n\nIntervention Description (Control Arm)\n\nStandard post-acute coronary syndrome care without specific treatment for iron deficiency. No intravenous or oral iron supplementation is administered per protocol.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'El Palmar', 'state': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'María Asunción Esteve Pastor, Doctor', 'role': 'CONTACT', 'email': 'masunep@gmail.com', 'phone': '+34968381027'}, {'name': 'María Asunción Esteve Pastor, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.93939, 'lon': -1.16095}}, {'city': 'Vigo', 'state': 'Pontevedra', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sergio Raposeiras Roubin, Doctor', 'role': 'CONTACT', 'email': 'raposeiras26@hotmail.com', 'phone': '+34886209106'}, {'name': 'Sergio Raposeiras Roubin, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '06080', 'city': 'Badajoz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Pérez Cervera, Doctor', 'role': 'CONTACT', 'email': 'jperezcervera@gmail.com', 'phone': '+34637998882'}, {'name': 'Javier Pérez Cervera, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Badajoz', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro Luis Cepas Guillén, Doctor', 'role': 'CONTACT', 'email': 'CEPAS@clinic.cat', 'phone': '+34662038836'}, {'name': 'Pedro Luis Cepas Guillén, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18016', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Diego Segura-Rodríguez, Doctor', 'role': 'CONTACT', 'email': 'diegoseguracardio@gmail.com', 'phone': '+34958023000'}, {'name': 'Diego Segura-Rodríguez, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Clínico San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '24071', 'city': 'León', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Thiscal López Lluva, Doctor', 'role': 'CONTACT', 'email': 'mtl.lluva@gmail.com', 'phone': '+34 652 684 953'}, {'name': 'Maria Thiscal López Lluva, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'David Vivas Balcones, Doctor', 'role': 'CONTACT', 'email': 'dvivas@secardiologia.es', 'phone': '+34658477955'}], 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gonzalo Luis Alonso Salinas, Doctor', 'role': 'CONTACT', 'email': 'gonzalol.alonso@gmail.com'}, {'name': 'Gonzalo Luis Alonso Salinas, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '46010', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Clara Bonanad Lozano, Doctor', 'role': 'CONTACT', 'email': 'clarabonanad@gmail.com', 'phone': '+34 686 10 70 71'}, {'name': 'Clara Bonanad Lozano, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Claudio Rivadulla Varela, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Clara Bonanad Lozano, Doctor', 'role': 'CONTACT', 'email': 'clarabonanad@gmail.com', 'phone': '+34 686 10 70 71'}, {'name': 'Claudio Rivadulla Varela, Doctor', 'role': 'CONTACT', 'email': 'c.rivare@hotmail.com', 'phone': '+34 625 11 46 86'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Investigación del Hospital Clínico de Valencia', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}