Written by Mary Marschner
Spoon Feed
For stable heart failure patients with iron deficiency, IV iron does not reduce deaths or hospitalizations for heart failure exacerbations.
A bit un-FAIR… the FAIR-HF2 DZHK05 trial doesn’t show benefit
Heart failure patients with iron deficiency anemia have more hospitalizations, worse functional scores, and worse quality of life scores than patients without it. Given issues with oral repletion like poor tolerance and malabsorption, it seems reasonable to think that IV iron repletion would help with outcomes.
The FAIR-HF2 DZHK05* trial, a multicenter, randomized, double-blind study, assessed the efficacy and safety of intravenous ferric carboxymaltose (FCM) in 1,105 patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. Over a median follow-up of 16.6 months, FCM did not significantly reduce any of its composite endpoints (i.e. death or hospitalization). Secondary outcomes, including total heart failure hospitalizations and outcomes in patients with transferrin saturation <20%, also showed no significant differences. However, FCM was well tolerated and associated with improved quality of life. These findings suggest that while FCM is safe and may enhance patient-reported outcomes, it does not significantly impact major clinical events in this population.
This study was mainly limited by the number of patients that dropped out during the study, which was more than one third! The study attributes this high number to COVID-19, but loss to follow-up continues to be a major problem post-pandemic.
How does this change my practice?
I’ve come around to IV iron in the last few years. I’m much more comfortable with the safety profile and less concerned about the possibility of infection than when I was in training, so I tend to use it more now. Although this study doesn’t show a difference in death or hospitalizations by treatment with IV iron, it does show a small difference in quality of life and functional outcomes, which, for heart failure, is significant to patients. So, I will be treating more of my heart failure patients with IV iron.
*Editor’s note: FAIR-HF2 DZHK05 is, perhaps, the worst acronym I’ve ever seen. Congratulations to the authors on this accomplishment! ~Clay Smith
Source
Intravenous Ferric Carboxymaltose in Heart Failure With Iron Deficiency: The FAIR-HF2 DZHK05 Randomized Clinical Trial. JAMA. 2025 Mar 30:e253833. doi: 10.1001/jama.2025.3833. Epub ahead of print. PMID: 40159390
