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Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED‐HF): a Phase III, anaemia correction, morbidity–mortality trial
Author(s) -
McMurray John J.V.,
Anand Inder S.,
Diaz Rafael,
Maggioni Aldo P.,
O'Connor Christopher,
Pfeffer Marc A.,
Polu Krishna R.,
Solomon Scott D.,
Sun Yan,
Swedberg Karl,
Tendera Michal,
Veldhuisen Dirk J.,
Wasserman Scott M.,
Young James B.
Publication year - 2009
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1093/eurjhf/hfp098
Subject(s) - darbepoetin alfa , medicine , heart failure , clinical endpoint , placebo , ejection fraction , erythropoietin , anemia , randomized controlled trial , quality of life (healthcare) , cardiology , surgery , alternative medicine , nursing , pathology
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.