[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633204":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":35,"locations":46,"responsibleParty":64,"collaborators":18,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":18,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":49,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Adjunctive anemia therapy and standard care","EXPERIMENTAL","In POET-IRON, the intervention with adjunctive, anemia corrective therapy will consist of:\n\nA one-time IV infusion of Ferriderisomaltose administered over 45-60 minutes. EPO will be administered at the same time as the iron infusion. Subsequently, EPO will be administrated according to hemoglobin levels in line with existing, therapeutic recommendations from Department of Hematology and Nephrology, Rigshospitalet. Intervention in patients who prior has not been treated with EPO, will begin with 150 μg Darbepoetin alfa with weekly measurements of hemoglobin. Patients randomized to adjunctive anemia therapy may receive a maximum of three doses of EPO treatment.\n\nVitamin supplementation (i.e. multivitamin, vitamin B12 and\u002For folate) will follow Danish clinical recommendations.",[13],"Drug: Adjunctive anemia therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care only","NO_INTERVENTION","At present, there are no specific recommendations for the treatment of anemia in patients with IE. Hence, anemia is managed according to standard practice at the clinician's discretion. The course of diagnostic and treatment is otherwise conducted in accordance with current guidelines.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Adjunctive anemia therapy","A one-time IV infusion of Ferriderisomaltose administered over 45-60 minutes.\n\nEPO will be administered at the same time as the iron infusion. Intervention in patients who prior has not been treated with EPO, will begin with 150 μg Darbepoetin alfa with weekly measurements of hemoglobin. Patients randomized to adjunctive anemia therapy may receive a maximum of three doses of EPO treatment.\n\nVitamin supplementation (i.e. multivitamin, vitamin B12 and\u002For folate) will follow Danish clinical recommendations.",[9],[26],"Iron and EPO therapy",[28,32],{"name":29,"affiliation":30,"role":31},"Henning Bundgaard, Professor, Dr. med","Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Denmark","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":30,"role":34},"Mia Marie Pries-Heje, MD, PhD","STUDY_CHAIR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Nareen S Nareen, MD","CONTACT","42329695","0045","nareen.sherzad.kader.rahman.01@regionh.dk",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Julie G Hjulmand, MD","29442666","julie.glud.hjulmand@regionh.dk",[47],{"facility":48,"status":49,"city":50,"state":18,"zip":18,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"The Heart Centre, Department of Cardiology, Rigshospitalet - Copenhagen University Hospital","RECRUITING","Copenhagen","Denmark","DK",{"type":54,"coordinates":55},"Point",[56,57],12.56553,55.67594,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":18,"email":63},"Nareen Kader, MD","004535450490","nareen.sherzad.kader.rahman@regionh.dk",{"type":31,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Henning Bundgaard","Professor, Chief Physician, Dr. med","100633204","phase-4-anemia-therapy-in-patients-with-infective-endocarditis-100633204",false,"NCT07523646","Anemia Therapy in Patients With Infective Endocarditis","Anemia Therapy in Patients With Infective Endocarditis (POET-IRON)","POET-IRON","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed bacterial endocarditis.\n* Hb ≤6.0 mmol\u002Fl\n* Stabilization criteria:\n\n  * Stable condition (patients with satisfactory clinical response to initial treatment)\n  * At least 10 days with IV administered antibiotic treatment and at least 7 days after surgery in cases of valve surgery.\n  * Transesophageal echocardiography (TEE) performed prior to randomization with no signs of abscess formation or valve abnormalities, which would require surgery.\n  * No fever for at least 48 hours prior to enrollment.No positive blood cultures within last 4 days prior to randomization.\n  * CRP \\\u003C 25 mg\u002FL OR \\> 25% reduction from peak value.\n  * Leucocytes \\\u003C15 mia.\u002FL OR \\> 25% reduction from peak value.\n\nExclusion Criteria:\n\n* Known or suspected immunocompromise (e.g., HIV infection, ongoing chemotherapy, systemic corti-costeroid treatment \\>20 mg prednisolone equivalent\u002Fday)\n* Inability to provide informed consent for participation\n* Relapsing infective endocarditis (endocarditis caused by the same microorganism within 6 months)\n* Allergy \u002F intolerance to EPO or iron therapy\n* Inability to complete a 6MWT\n* Hematological conditions, that contradicts use of IV iron therapy\n* Death prior to clinical stabilization\n* Failure to fulfill criteria of clinical stabilization","ALL","18 Years",{"count":78,"type":79},74,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","Infective endocarditis (IE) is a bacterial infection of the heart valves, inserted material or surrounding struc-tures and is associated with a high morbidity and mortality. In patients with IE, anemia is considered to result from the underlying infection, prolonged sustained inflammatory response due to the often slow natural course of the disease, and coexisting comorbidities.\n\nPrevious studies have found that moderate to severe anemia is associated with a markedly higher risk of mortality in the 6-months recovery phase following treatment for IE. In many cardiac patients and patients with chronic inflammation, randomized trials have shown benefit of treatment of anemia with adjunctive therapy i.e., vitamins (vitamin B12\u002Ffolic acid), intravenous iron, and erythropoiesis stimulating agents in alleviating anemia, without increased risk of infection. Despite these findings, anemia screening and management are not addressed in current endocarditis guidelines. Thus, in patients with IE and anemia, adjunctive treatment of the anemia might be beneficial for recovery and improve outcomes.\n\nThe aim of POET-IRON is to assess the efficacy of adjunctive anemia treatment in patients with IE, using intravenous iron supplementation, erythropoietin-stimulated erythropoiesis, and dietary optimization including vitamins if necessary, and its effect on hemoglobin levels compared to standard care.\n\nThe investigators hypothesize that this intervention is safe and will increase hemoglobin concentration, thereby alleviating symptoms of anemia and improving clinical outcomes through enhanced oxygen-carrying capacity, tissue oxygenation, and functional status.",[85,86],"Infective Endocarditis (IE)","Severe Anemia",[88,89,90],"Anemia","Infective Endocarditis","Inflammation","2026-05-26",{"date":93,"type":94},"2026-05-29","ACTUAL",{"date":96,"type":94},"2026-05-15",{"date":98,"type":79},"2028-08",{"name":5,"class":6},1]