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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

Ponikowski, Piotr ; Kirwan, Bridget Anne ; Anker, Stefan D. ; Dorobantu, Maria ; Drozdz, Jarosław ; Fabien, Vincent ; Filippatos, Gerasimos ; Haboubi, Teba ; Keren, Andre and Khintibidze, Irakli , et al. (2019) In European Journal of Heart Failure 21(12). p.1651-1658
Abstract

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... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
Acute heart failure, Cardiovascular mortality, Ferric carboxymaltose, Iron deficiency, Recurrent heart failure hospitalizations
in
European Journal of Heart Failure
volume
21
issue
12
pages
8 pages
publisher
Elsevier
external identifiers
  • pmid:31883356
  • scopus:85077183438
ISSN
1388-9842
DOI
10.1002/ejhf.1710
language
English
LU publication?
no
id
263342c4-f868-4989-a5be-c40a8560fedc
date added to LUP
2020-01-10 15:03:01
date last changed
2024-04-17 03:20:48
@article{263342c4-f868-4989-a5be-c40a8560fedc,
  abstract     = {{<p>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 &lt;100 ng/mL or 100–299 ng/mL if transferrin saturation &lt;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.</p>}},
  author       = {{Ponikowski, Piotr and Kirwan, Bridget Anne and Anker, Stefan D. and Dorobantu, Maria and Drozdz, Jarosław and Fabien, Vincent and Filippatos, Gerasimos and Haboubi, Teba and Keren, Andre and Khintibidze, Irakli and Kragten, Hans and Martinez, Felipe A. and McDonagh, Theresa and Metra, Marco and Milicic, Davor and Nicolau, José C. and Ohlsson, Marcus and Parhomenko, Alexander and Pascual-Figal, Domingo A. and Ruschitzka, Frank and Sim, David and Skouri, Hadi and van der Meer, Peter and Jankowska, Ewa A.}},
  issn         = {{1388-9842}},
  keywords     = {{Acute heart failure; Cardiovascular mortality; Ferric carboxymaltose; Iron deficiency; Recurrent heart failure hospitalizations}},
  language     = {{eng}},
  number       = {{12}},
  pages        = {{1651--1658}},
  publisher    = {{Elsevier}},
  series       = {{European Journal of Heart Failure}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1002/ejhf.1710}},
  doi          = {{10.1002/ejhf.1710}},
  volume       = {{21}},
  year         = {{2019}},
}