Anemia Therapy in People With Infective Endocarditis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 trial explores the use of adjunctive anemia therapy in adults with confirmed infective endocarditis and severe anemia. Eligible participants must have stabilized on initial treatment and meet specific clinical criteria before randomization. The study focuses on whether correcting anemia can improve short- to medium-term outcomes without increasing infection risk. Primary safety and feasibility of the anemia therapy are evaluated, alongside signals of potential clinical benefit.

Why it matters

Who can join: the full rules

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

Where it's running

• The Heart Centre, Department of Cardiology, Rigshospitalet - Copenhagen University Hospital
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Henning Bundgaard, Professor, Dr. med — Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Denmark
• Study coordinator: Nareen S Nareen, MD
• Email: nareen.sherzad.kader.rahman.01@regionh.dk
• Phone: 42329695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.