Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity–mortality trial
1 British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK
2 University of Minnesota Medical School and VA Medical Center, Minneapolis, MN, USA
3 Estudios Clínicos Latinoamérica, Rosario, Argentina
4 ANMCO Research Center, Via la Marmora, Florence, Italy
5 Duke University Medical Center, Durham, NC, USA
6 Brigham and Women's Hospital, Boston, MA, USA
7 Clinical Development, Amgen Inc., CA, USA
8 Department of Biostatistics, Amgen Inc., CA, USA
9 Department of Emergency and Cardiovascular Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden
10 Division of Cardiology, Medical University of Silesia, Katowice, Poland
11 University Medical Center Groningen, Groningen, The Netherlands
12 Department of Medicine, Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH, USA
* Corresponding author. Tel: +44 141 211 1838, Fax: +44 141 211 2252, Email: j.mcmurray{at}bio.gla.ac.uk
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Abstract |
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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 
40%, and a haemoglobin (Hb) consistently 12.0 g/dL but 
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 
1150 subjects experience a primary endpoint.
Key Words: Heart failure • Anaemia
Received February 3, 2009; Revised May 26, 2009; Accepted May 27, 2009
RED-HF Committees and Investigators are listed in the Trial Committees section. A full list of Investigators is available online as Supplementary Material.
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