1. 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
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Davor Miličić, Peter van der Meer, Bridget Anne Kirwan, Piotr Ponikowski, Jarosław Drożdż, David Sim, Irakli Khintibidze, Marcus Andreas Ohlsson, Hadi Skouri, Frank Ruschitzka, Felipe Martinez, Andre Keren, Maria Dorobantu, Stefan D. Anker, Alexander Parhomenko, Marco Metra, Vincent Fabien, Jose C. Nicolau, Teba Haboubi, Ewa A. Jankowska, Gerasimos Filippatos, Domingo A. Pascual-Figal, Theresa McDonagh, Hans Kragten, Cardiovascular Centre (CVC), Restoring Organ Function by Means of Regenerative Medicine (REGENERATE), University of Zurich, and Ponikowski, Piotr
- Subjects
Male ,Placebo-controlled study ,Recurrent heart failure hospitalizations ,030204 cardiovascular system & hematology ,Ferric Compounds ,THERAPY ,DISEASE ,0302 clinical medicine ,Quality of life ,RISK ,OUTCOMES ,Ejection fraction ,Anemia, Iron-Deficiency ,DEATH ,Iron deficiency ,Middle Aged ,PREVALENCE ,Hospitalization ,Survival Rate ,Treatment Outcome ,Injections, Intravenous ,10209 Clinic for Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,Switzerland ,medicine.medical_specialty ,Cardiovascular mortality ,Anemia ,610 Medicine & health ,Acute heart failure ,Ferric carboxymaltose ,Placebo ,DIAGNOSIS ,2705 Cardiology and Cardiovascular Medicine ,03 medical and health sciences ,Double-Blind Method ,Internal medicine ,medicine ,Humans ,ANEMIA ,Maltose ,Aged ,Retrospective Studies ,Heart Failure ,Inpatients ,Dose-Response Relationship, Drug ,Transferrin saturation ,business.industry ,medicine.disease ,Heart failure ,REGISTRY ,Quality of Life ,business ,Follow-Up Studies - 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 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
- Published
- 2019