Congestive Heart Failure - RED HF
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Trial Sponsor
Amgen
Principal Investigator
Stephen Jennison, MD / Nasar Nallamothu, MD
Trial Name
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
Purpose
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 HF in subjects with symptomatic left ventricular systolic dysfunction and anemia.
Details
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 subjects 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.
Phase
Phase III
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Expected Enrollment
3400
Study Start
June 2006
Primary Outcome Measures
- To determine the efficacy of darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening HF in subjects with symptomatic left ventricular systolic dysfunction and anemia.
Secondary Outcome Measures
- change from baseline to month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
- change from baseline to month 6 in KCCQ Symptom Frequency Score
- To evaluate the effects of treatment with darbepoetin alfa on
- time to death from any cause
- time to cardiovascular death or first hospital admission for worsening HF, whichever occurs first
Eligibility
Ages Eligible for Study
18 years and above
Genders Eligible for Study
Both
Inclusion Criteria
- HF of at least 3 months duration and of NYHA class II, III, or IV
- hemoglobin between 9.0 g/dL and 12.0 g/dL
- left ventricular ejection fraction equal to or less than 40%
Exclusion Criteria
- Transferrin saturation (Tsat) < 15%
- Blood pressure > 160/100 mm Hg
- Heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization
- Recipient of a major organ transplant or receiving renal replacement therapy
- Serum creatinine > 3.0 mg/dL (> 265 µmol/L)
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