Anemia Therapy in Patients With Infective Endocarditis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Confirmed bacterial endocarditis.

Hb ≤6.0 mmol/l

Stable condition (patients with satisfactory clinical response to initial treatment)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adjunctive anemia therapy

    Drug

    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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Adjunctive anemia therapy and standard careExperimental treatment 1 intervention
Group B: Standard care onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary endpoint

Change from baseline in 6-minute walk test distance (m)

Time frame
Six weeks from time of randomization

Secondary outcomes

1

Difference in physical capacity three months after randomization

Change from baseline in 6-minute walk test distance (m)

Time frame
Three months
2

Hemoglobin changes over time from baseline

Change of hemoglobin concentration (mmol/L)

Time frame
Four weeks and three months after randomization
3

Percentage of subjects with no anemia / normalized hemoglobin

Time (days) to sex-specific hemoglobin normalization

Time frame
Four weeks and three months after randomization
4

Profiling of advanced iron metabolic markers

Change from baseline in hepcidin level (ng/mL)

Time frame
Three months after randomization

Other outcomes

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