title: Determinants of quality of life of patients with heart failure and iron deficiency treated with ferric carboxymaltose: FAIR-HF sub-analysis.
abstract: BACKGROUND
  Heart failure (HF) is a burden to patients and health care systems. The objectives of HF treatment are to improve health related quality of life (HRQoL) and reduce mortality and morbidity. We aimed to evaluate determinants of health-related quality of life (HRQoL) in patients with iron deficiency and HF treated with intravenous (i.v.) iron substitution or placebo.
  
  
  METHODS
  A randomised, double-blind, placebo-controlled trial (n = 459) in iron-deficient chronic heart failure (CHF) patients with or without anaemia studied clinical and HRQoL benefits of i.v. iron substitution using ferric carboxymaltose (FCM) over a 24-week trial period. Multivariate analysis was carried out with various clinical variables as independent variables and HRQoL measures as dependent variables.
  
  
  RESULTS
  Mean change from baseline of European Quality of Life - 5 Dimensions (EQ-5D) (value set-based) utilities (on a 0 to 100 scale) at week 24 was 8.91 (i.v. iron) and 0.68 (placebo; p < 0.01). In a multivariate analysis excluding baseline HRQoL, a higher exercise tolerance and i.v. iron substitution positively influenced HRQoL, whereas impaired renal function and a history of stroke had a negative effect. The level of HRQoL was also influenced by country of residence. When baseline HRQoL was factored in, the multivariate model remained stable.
  
  
  CONCLUSIONS
  In this study, i.v. iron substitution, exercise tolerance, stroke, country of residence and renal function influenced measures of HRQoL in patients with heart failure and iron deficiency.
authors.affiliation: Institute of Pharmaceutical Medicine/ECPM, Universität Basel, Basel, Switzerland. Electronic address: florian.gutzwiller@unibas.ch.
authors.forename: Florian S
authors.initials: FS
authors.lastname: Gutzwiller
authors.forename: Alena M
authors.initials: AM
authors.lastname: Pfeil
authors.forename: Josep
authors.initials: J
authors.lastname: Comin-Colet
authors.forename: Piotr
authors.initials: P
authors.lastname: Ponikowski
authors.forename: Gerasimos
authors.initials: G
authors.lastname: Filippatos
authors.forename: Claudio
authors.initials: C
authors.lastname: Mori
authors.forename: Peter G
authors.initials: PG
authors.lastname: Braunhofer
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Szucs
authors.forename: Matthias
authors.initials: M
authors.lastname: Schwenkglenks
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
mesh_terms: D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D004311:Double-Blind Method; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006333:Heart Failure / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D006801:Humans; D038622:Internationality; D008297:Male; D008320:Maltose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; C522335:ferric carboxymaltose; D008320:Maltose
keywords: Anaemia; Ferric carboxymaltose; Heart failure; Iron deficiency; Multivariate analysis; Quality of life