Anemia Therapy in Patients With Infective Endocarditis

NCT07523646 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: H-25070613
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Anemia; Infective Endocarditis; Inflammation

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

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

  Six weeks from time of randomization

Secondary Outcomes (13)

• Difference in physical capacity three months after randomization

  Three months

• Hemoglobin changes over time from baseline

  Four weeks and three months after randomization

• Percentage of subjects with no anemia / normalized hemoglobin

  Four weeks and three months after randomization

• Profiling of advanced iron metabolic markers

  Three months after randomization

• Cardiac functional status and hemodynamic parameters

  From baseline to six and 12 weeks after randomizatoin

Study Arms (2)

Adjunctive anemia therapy and standard care

EXPERIMENTAL

In POET-IRON, the intervention with adjunctive, anemia corrective therapy will consist of: A 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. Vitamin supplementation (i.e. multivitamin, vitamin B12 and/or folate) will follow Danish clinical recommendations.

Drug: Adjunctive anemia therapy

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.

Interventions

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.

Also known as: Iron and EPO therapy

Adjunctive anemia therapy and standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Related Publications (36)

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MeSH Terms

Conditions

Endocarditis; Anemia; Inflammation

Interventions

Iron

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Henning Bundgaard, Professor, Dr. med

  Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Mia Marie Pries-Heje, MD, PhD

  Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Denmark

  STUDY CHAIR

Central Study Contacts

Nareen S Nareen, MD

CONTACT

42329695; nareen.sherzad.kader.rahman.01@regionh.dk

Julie G Hjulmand, MD

CONTACT

29442666; julie.glud.hjulmand@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician, Dr. med

Model Details: An investigator-initiated, prospective open-label randomized trial

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04