A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia
The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.
Several epidemiological studies have demonstrated an association between HF and anemia and correlation of increased risk for mortality and hospitalization with low hemoglobin in patients with HF. Earlier single-center interventional studies suggest that meaningful clinical benefits may be achieved by raising hemoglobin concentration in patients with symptomatic HF and anemia. Data from Amgen's completed phase 2 multi-center studies support this hypothesis and show that darbepoetin alfa is well tolerated in patients with symptomatic left ventricular systolic dysfunction and anemia and effectively raises hemoglobin. The pivotal phase 3 Study 20050222 RED-HF Trial is evaluating the effect of treatment with darbepoetin alfa on the composite risk of all-cause mortality or hospitalization for worsening HF in patients with symptomatic left ventricular systolic dysfunction and anemia. This study also evaluates the effect of darbepoetin alfa treatment on all-cause death, on cardiovascular death or hospitalization for worsening HF, and on patient-reported quality-of-life outcomes.
Inclusion Criteria:
Exclusion Criteria:
Capital Federal, Buenos Aires C1408INH, Argentina
Capital Federal, Buenos Aires C1426ANZ, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires 1118, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires 1425, Argentina
Capital Federal, C1221ADC, Argentina
Riberão Preto, São Paulo 14048-900, Brazil
São José Do Rio Preto, São Paulo 15090-000, Brazil
São Paulo, São Paulo 04025-002, Brazil
North York, Ontario M2K 2W2, Canada
St-Jérôme, Quebec J7Z 5T3, Canada
København Ø, 2011, Denmark
København S, 2300, Denmark
Køge, 4600, Denmark
Pärnu, 80010, Estonia
Créteil Cedex, 94010, France
Bad Tölz, 83646, Germany
Göttingen, 37075, Germany
Georgsmarienhütte, 49124, Germany
Köln, 50924, Germany
Nürnberg, 90402, Germany
Hyderabad, Andhra Pradesh 500 001, India
Hyderabad, Andhra Pradesh 500 033, India
Hyderabad, Andhra Pradesh 500 063, India
Askelon, 78278, Israel
Beer Yaakov, 70300, Israel
Cetraro CS, 87022, Italy
Cortona AR, 52044, Italy
Forlì, 47100, Italy
Oliveto Citra SA, 84020, Italy
Palmanova UD, 33057, Italy
Rozzano MI, 20089, Italy
San Bonifacio VR, 37047, Italy
Guadajalara, Jalisco 44100, Mexico
Ã…lesund, 6026, Norway
Córdoba, AndalucÃ-a 14004, Spain
Málaga, AndalucÃ-a 29010, Spain
Majadhonda, Madrid 28222, Spain
Ã-rebro, 701 85, Sweden
Göteborg, 413 45, Sweden
Göteborg, 416 85, Sweden
Linköping, 581 85, Sweden
Malmö, 205 02, Sweden
Mölndal, 431 80, Sweden
Umeå, 901 85, Sweden