Anemia Therapy in Patients With Infective Endocarditis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Primary endpoint — Six weeks from time of randomization
  Change from baseline in 6-minute walk test distance (m)

Trial sites (1)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark