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Anemia Therapy in Patients With Infective Endocarditis

NCT07523646 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-05-29

No results posted yet for this study

Summary

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 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.

The 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.

The 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.

Conditions

  • Infective Endocarditis (IE)
  • Severe Anemia

Interventions

DRUG

Adjunctive anemia therapy

A one-time IV infusion of Ferriderisomaltose administered over 45-60 minutes. EPO 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. Vitamin supplementation (i.e. multivitamin, vitamin B12 and/or folate) will follow Danish clinical recommendations.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Henning Bundgaard, Professor, Dr. med · Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Denmark

  • Mia Marie Pries-Heje, MD, PhD · Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2028-04-30
Completion
2028-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07523646 on ClinicalTrials.gov