Journal
EUROPEAN JOURNAL OF HEART FAILURE
Volume 21, Issue 12, Pages 1651-1658Publisher
WILEY
DOI: 10.1002/ejhf.1710
Keywords
Acute heart failure; Iron deficiency; Ferric carboxymaltose; Recurrent heart failure hospitalizations; Cardiovascular mortality
Categories
Funding
- Vifor Pharma
- Glattbrugg, Switzerland
- Vifor Int
- Bayer
- Boehringer Ingelheim
- Servier
- Novartis
- Sanofi
- Janssen Research Development
- Vifor
- Amgen
- AstraZenca
- Novo Nordisk
- CSL Behring
- Pfizer
- Roche
- SJM/Abbott
- Zoll
- Astra Zeneca
- Cardiorentis
- Mars and Heartware
- Ionis
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Aims Iron deficiency (ID) is a common co-morbidity in heart failure (HF), associated with impaired functional capacity, poor quality of life and increased morbidity and mortality. Treatment with intravenous (i.v.) ferric carboxymaltose (FCM) has shown improvements in functional capacity, symptoms and quality of life in stable HF patients with reduced ejection fraction. The effect of i.v. iron supplementation on morbidity and mortality in patients hospitalised for acute HF (AHF) and who have ID has yet to be established. The objective of the present article is to present the rationale and design of the AFFIRM-AHF trial ( NCT02937454) which will investigate the effect of i.v. FCM (vs. placebo) on recurrent HF hospitalisations and cardiovascular (CV) mortality in iron-deficient patients hospitalised for AHF. Methods AFFIRM-AHF is a multicentre, randomised (1:1), double-blind, placebo-controlled trial which recruited 1100 patients hospitalised for AHF and who had iron deficiency ID defined as serum ferritin <100 ng/mL or 100-299 ng/mL if transferrin saturation <20%. Eligible patients were randomised (1:1) to either i.v. FCM or placebo and received the first dose of study treatment just prior to discharge for the index hospitalisation. Patients will be followed for 52 weeks. The primary outcome is the composite of recurrent HF hospitalisations and CV mortality. The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes. Conclusion The AFFIRM-AHF trial will evaluate, compared to placebo, the effect of i.v. FCM on morbidity and mortality in iron-deficient patients hospitalised for AHF.
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