Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial.

Journal Article (Clinical Trial, Phase III;Journal Article)

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 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.

Full Text

Duke Authors

Cited Authors

  • McMurray, JJV; Anand, IS; Diaz, R; Maggioni, AP; O'Connor, C; Pfeffer, MA; Polu, KR; Solomon, SD; Sun, Y; Swedberg, K; Tendera, M; van Veldhuisen, DJ; Wasserman, SM; Young, JB; RED-HF Committees and Investigators,

Published Date

  • August 2009

Published In

Volume / Issue

  • 11 / 8

Start / End Page

  • 795 - 801

PubMed ID

  • 19633103

Electronic International Standard Serial Number (EISSN)

  • 1879-0844

Digital Object Identifier (DOI)

  • 10.1093/eurjhf/hfp098


  • eng

Conference Location

  • England