Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial.
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.
McMurray
John J V
JJ
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. j.mcmurray@bio.gla.ac.uk
Anand
Inder S
IS
Diaz
Rafael
R
Maggioni
Aldo P
AP
O'Connor
Christopher
C
Pfeffer
Marc A
MA
Polu
Krishna R
KR
Solomon
Scott D
SD
Sun
Yan
Y
Swedberg
Karl
K
Tendera
Michal
M
van Veldhuisen
Dirk J
DJ
Wasserman
Scott M
SM
Young
James B
JB
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
D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa