title: Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial.
abstract: BACKGROUND
  Patients with heart failure (HF) and anaemia have greater functional impairment, worse symptoms, increased rates of hospital admission, and a higher risk of death, compared with non-anaemic HF patients. Whether correcting anaemia can improve outcomes is unknown.
  
  
  OBJECTIVE
  The Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF; Clinical Trials.gov NCT 003 58215) was designed to evaluate the effect of the long-acting erythropoietin-stimulating agent darbepoetin alfa on mortality and morbidity (and quality of life) in patients with HF and anaemia.
  
  
  METHODS
  Approximately 2600 patients with New York Heart Association class II-IV, an ejection fraction < or =40%, and a haemoglobin (Hb) consistently < or =12.0 g/dL but > or =9.0 g/dL will be enrolled. Patients are randomized 1:1 to double-blind subcutaneous administration of darbepoetin alfa or placebo. Investigators are also blinded to Hb measurements and darbepoetin alfa is dosed to achieve an Hb concentration of 13.0 g/dL (but not exceeding 14.5 g/dL) with sham adjustments of the dose of placebo. The primary endpoint is the time to death from any cause or first hospital admission for worsening HF, whichever occurs first. The study will complete when approximately 1150 subjects experience a primary endpoint.
authors.affiliation: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. j.mcmurray@bio.gla.ac.uk
authors.forename: John J V
authors.initials: JJ
authors.lastname: McMurray
authors.forename: Inder S
authors.initials: IS
authors.lastname: Anand
authors.forename: Rafael
authors.initials: R
authors.lastname: Diaz
authors.forename: Aldo P
authors.initials: AP
authors.lastname: Maggioni
authors.forename: Christopher
authors.initials: C
authors.lastname: O'Connor
authors.forename: Marc A
authors.initials: MA
authors.lastname: Pfeffer
authors.forename: Krishna R
authors.initials: KR
authors.lastname: Polu
authors.forename: Scott D
authors.initials: SD
authors.lastname: Solomon
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
authors.forename: Karl
authors.initials: K
authors.lastname: Swedberg
authors.forename: Michal
authors.initials: M
authors.lastname: Tendera
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: van Veldhuisen
authors.forename: Scott M
authors.initials: SM
authors.lastname: Wasserman
authors.forename: James B
authors.initials: JB
authors.lastname: Young
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy*; D000068256:Darbepoetin alfa; D004311:Double-Blind Method; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012107:Research Design; D013318:Stroke Volume; D011795:Surveys and Questionnaires; D016277:Ventricular Function, Left
chemical_list: D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa