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

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art_PONIKOWSKI_Rationale_and_design_of_the_AFFIRMAHF_trial_a_2019.PDF (971.16 KB)
Citações na Scopus
40
Tipo de produção
article
Data de publicação
2019
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
WILEY
Autores
PONIKOWSKI, Piotr
KIRWAN, Bridget-Anne
ANKER, Stefan D.
DOROBANTU, Maria
DROZDZ, Jaroslaw
FABIEN, Vincent
FILIPPATOS, Gerasimos
HABOUBI, Teba
KEREN, Andre
KHINTIBIDZE, Irakli
Citação
EUROPEAN JOURNAL OF HEART FAILURE, v.21, n.12, p.1651-1658, 2019
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
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.
Palavras-chave
Acute heart failure, Iron deficiency, Ferric carboxymaltose, Recurrent heart failure hospitalizations, Cardiovascular mortality
URI
https://observatorio.fm.usp.br/handle/OPI/35411
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Coleções
Artigos e Materiais de Revistas Científicas - FM/MCP
Artigos e Materiais de Revistas Científicas - HC/InCor
Artigos e Materiais de Revistas Científicas - LIM/11