Heart failure & cardiomyopathies

Rationale and Design of the FAIR-HF2-DZHK05 Trial: Ferric Carboxymaltose Assessment of Morbidity and Mortality in Patients with Iron Deficiency and Chronic Heart Failure

Eur J Heart FailPublished Design paper of a randomised controlled trial

Study context

Population
Chronic heart failure (HF) with LVEF ≤45% and iron deficiency (serum ferritin <100 ng/ml or 100–299 ng/ml with transferrin saturation <20%)recruited
Participants
1,105 participants
Planned comparison
Intravenous (IV) ferric carboxymaltose vs placebo
Primary endpoint
Three primary hypotheses: (i) time to first CV death or HF hospitalization; (ii) rate of total (first and recurrent) HF hospitalizations; (iii) time to first CV death or HF hospitalization in patients with transferrin saturation <20% at baseline
Follow-up
Estimated median over 2 years
Methodological detailsinvestigator-initiated, multicentre, double-blind, placebo-controlled
  • Investigator-initiated
  • Multicentre
  • Double-blind
  • Placebo-controlled

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Rationale and Design of the FAIR-HF2-DZHK05 Trial: Ferric Carboxymaltose Assessment of Morbidity and Mortality in Patients with Iron Deficiency and Chronic Heart Failure. Eur J Heart Fail. Published 28 January 2025. doi:10.1002/ejhf.3574

Summarised from the published abstract; every number is checked against it

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