Premium
Rationale and design of the AFFIRM‐AHF trial: a randomised, double‐blind, placebo‐controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron‐deficient patients admitted for acute heart failure
Author(s) -
Ponikowski Piotr,
Kirwan BridgetAnne,
Anker Stefan D.,
Dorobantu Maria,
Drozdz Jarosław,
Fabien Vincent,
Filippatos Gerasimos,
Haboubi Teba,
Keren Andre,
Khintibidze Irakli,
Kragten Hans,
Martinez Felipe A.,
McDonagh Theresa,
Metra Marco,
Milicic Davor,
Nicolau José C.,
Ohlsson Marcus,
Parhomenko Alexander,
PascualFigal Domingo A.,
Ruschitzka Frank,
Sim David,
Skouri Hadi,
Meer Peter,
Jankowska Ewa A.
Publication year - 2019
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.1710
Subject(s) - medicine , placebo , transferrin saturation , heart failure , iron deficiency , ejection fraction , quality of life (healthcare) , ferritin , randomized controlled trial , placebo controlled study , double blind , anemia , alternative medicine , nursing , pathology
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 ( ClinicalTrials.gov 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.