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Anemia Therapy in Patients With Infective Endocarditis

RecruitingPhase 4Ages 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT07523646 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Previous 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/folic acid), intravenous iron, and erythropoiesis stimulating agents in alleviating anemia, without increased risk of infection. Despite these findings, anemia screeni

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years or older * Confirmed bacterial endocarditis. * Hb ≤6.0 mmol/l * Stabilization criteria: * Stable condition (patients with satisfactory clinical response to initial treatment) * At least 10 days with IV administered antibiotic treatment and at least 7 days after surgery in cases of valve surgery. * Transesophageal echocardiography (TEE) performed prior to randomization with no signs of abscess formation or valve abnormalities, which would require surgery. * No fever for at least 48 hours prior to enrollment.No positive blood cultures within last 4 days prior to randomization. * CRP \< 25 mg/L OR \> 25% reduction from peak value. * Leucocytes \<15 mia./L OR \> 25% reduction from peak value. Exclusion Criteria: * Known or suspected immunocompromise (e.g., HIV infection, ongoing chemotherapy, systemic corti-costeroid treatment \>20 mg prednisolone equivalent/day) * Inability to provide informed consent for participation * Relapsing infective endocarditis (endocarditis caused by the same microorganism within 6 months) * Allergy / intolerance to EPO or iron therapy * Inability to complete a 6MWT * Hematological conditions, that contradicts use of IV iron therapy * Death prior to clinical stabilization * Failure to fulfill criteria of clinical stabilization
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What it tests

  • Adjunctive anemia therapy
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Where

1 site
The Heart Centre, Department of Cardiology, Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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