RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial

Amgen

Status and phase: Completed; Phase 3

Conditions: Anemia; Ventricular Dysfunction; Heart Failure; Congestive Heart Failure; Cardiovascular Disease

Treatments: Drug: Darbepoetin alfa; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00358215

20050222

RED-HF™ Trial

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,278 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heart failure of at least 3 months duration and of New York Heart Association (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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,278 participants in 2 patient groups, including a placebo group

Darbepoetin alfa

Experimental group

Description:

Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.

Treatment:

Drug: Darbepoetin alfa

Placebo

Placebo Comparator group

Description:

Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.

Treatment:

Drug: Placebo