Heart failure & cardiomyopathiesRandomised controlled trial
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
- Design paper of a randomised controlled trial
- investigator-initiated
- multicentre
- double-blind
- placebo-controlled
Authors' conclusion
The FAIR-HF2 will evaluate the efficacy of FCM in patients with HFrEF in improving cardiovascular outcomes by utilizing a more aggressive approach towards iron supplementation ensuring prevention of transitional ID after initial repletion targets have been met.
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
- 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
Primary result
As reported in the abstract
- design paper; no results reported
- familywise type I error controlled by Hochberg procedure (alpha 0.05)
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