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.

Anand, I. S. (author)
Diaz, R. (author)
Maggioni, A. P. (author)
O'Connor, C. (author)
Pfeffer, M. A. (author)
Polu, K. R. (author)
Solomon, S. D. (author)
Sun, Y. (author)
Swedberg, Karl,1944Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för akut och kardiovaskulär medicin,Institute of Medicine, Department of Emergeny and Cardiovascular Medicine(Swepub:gu)xsweka (author)
Tendera, M. (author)
van Veldhuisen, D. J. (author)
Wasserman, S. M. (author)
Young, J. B. (author)
Göteborgs universitetInstitutionen för medicin, avdelningen för akut och kardiovaskulär medicin (creator_code:org_t)

By the author/editor: McMurray, J. J.; Anand, I. S.; Diaz, R.; Maggioni, A. P.; O'Connor, C.; Pfeffer, M. A.; show more...; Polu, K. R.; Solomon, S. D.; Sun, Y.; Swedberg, Karl, ...; Tendera, M.; van Veldhuisen, ...; Wasserman, S. M.; Young, J. B.; show less...

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Cardiac and Card ...

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