Reduction of events with darbepoetin alfa in heart failure (RED-HF)™ trial

Young, J.B. et al. (2006) Reduction of events with darbepoetin alfa in heart failure (RED-HF)™ trial. Journal of Cardiac Failure, 12(6), S77. (doi: 10.1016/j.cardfail.2006.06.264)

Abstract

Patients with heart failure (HF) suffer from a high burden of morbidity and mortality. Despite advances in treatment, the 5-year mortality rate for HF patients is 50%, and HF is the leading cause of hospitalization among people > 65 years. Approx. 20–30% of HF patients are anemic. Observational data suggest that anemia is an independent risk factor for increased morbidity and mortality in patients with HF. Recent preliminary interventional studies have shown that treatment of anemia with erythropoiesis-stimulating proteins (ESP) in HF patients was well tolerated and led to improvements in exercise tolerance, symptoms, and health-related quality of life. The RED-HF Trial is a global, multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to determine the impact of treatment of anemia (baseline hemoglobin [Hb] 9.0–12.0 g/dL) with the long-acting ESP darbepoetin alfa on morbidity and mortality in approx. 3,400 patients with symptomatic left ventricular systolic dysfunction. Subjects will be randomly assigned 1:1 to receive either darbepoetin alfa or placebo. Darbepoetin alfa will be initiated at 0.75 mcg/kg once every two weeks, and will be titrated until the target Hb of 13.0–14.5 g/dL is achieved. The dose will then be doubled and the administration interval extended to once monthly. The primary endpoint is a composite of all-cause death or first hospitalization for worsening HF. The study will conclude approx. 3 years after the first subject is enrolled, when approx. 1,450 subjects have experienced a primary endpoint event. Despite growing awareness that anemia in HF is associated with worse symptoms and outcomes, current guidelines do not address the management of anemia in patients with HF, and no large clinical trials have determined the effect of treatment of anemia on morbidity and mortality in these patients. The RED-HF Trial will provide the critical data needed to determine whether treatment of anemia improves outcomes in patients with HF.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McMurray, Professor John
• Authors: Young, J.B., Anand, I.S., Diaz, R., Maggioni, A.P., McMurray, J.J.V., O'Connor, C., Pfeffer, M.A., Solomon, S., Tendera, M., van Veldhuisen, D.J., Wasserman, S.M., and Swedberg, K.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: Journal of Cardiac Failure
• Publisher: Elsevier
• ISSN: 1071-9164
• ISSN (Online): 1532-8414