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


Tracking Information

Start Date  ICMJEJune 2006
Estimated Primary Completion DateDecember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
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. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: July 27, 2006)
To determine the efficacy of darbepoetin alfa compared with 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.
Change HistoryComplete list of historical versions of study NCT00358215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: January 31, 2008)
  • To evaluate the effects of treatment with darbepoetin alfa on time to cardiovascular death or first hospital admission for worsening HF, whichever occurs first [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • To evaluate the effects of treatment with darbepoetin alfa on change from baseline to month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • To evaluate the effects of treatment with darbepoetin alfa on time to death from any cause [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • To evaluate the effects of treatment with darbepoetin alfa on change from baseline to month 6 in KCCQ Symptom Frequency Score [ Time Frame: Six months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: July 27, 2006)
  • "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
  • 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

Descriptive Information

Brief Title  ICMJERED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
Official Title  ICMJEA 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
Brief Summary

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.

Detailed 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 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.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Heart Failure
  • Anemia
  • Cardiovascular Disease
  • Ventricular Dysfunction
  • Congestive Heart Failure
Intervention  ICMJE
  • Drug: Darbepoetin alfa

    Starting dose: 0.75 mcg/kg subcutaneously Q2W

    Subsequent doses:

    - Darbepoetin alfa group to receive darbepoetin alfa titrated to achieve Hb target of 13.0 g/dL, not to exceed 14.5 g/dL

  • Drug: Placebo
    Placebo group to receive volume and dose frequency changes resembling titration dosing in the treatment group
Study Arms / Comparison Groups
  • Active: Experimental
    Intervention: Drug: Darbepoetin alfa
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo
Publications *McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801.

Recruitment Information

Estimated Enrollment  ICMJE2600
Estimated Completion DateApril 2012
Estimated Primary Completion DateDecember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Amgen Call Center866-572-6436
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Switzerland,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00358215
Responsible PartyGlobal Development Leader, Amgen Inc.
Study ID Numbers  ICMJE20050222, RED-HF™ Trial
Study Sponsor  ICMJEAmgen
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:MDAmgen
Information Provided ByAmgen