Phase 3
N=2,278
RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
Heart Failure · Anemia · Cardiovascular Disease · Ventricular Dysfunction · Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00358215 ↗Enrolled (actual)
2,278
Serious AEs
67.0%
Results posted
Dec 2013
Primary outcome: Primary: Time to All Cause Death or First Hospitalization for Worsening Heart Failure — 1260.0; 1184.0 days — p=0.871
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Darbepoetin alfa (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to All Cause Death or First Hospitalization for Worsening Heart Failure |
1260.0; 1184.0 | 0.871 |
| SECONDARY Time to Death From Any Cause |
1637.0; 1629.0 | 0.512 |
| SECONDARY Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure |
1414.0; 1395.0 | 0.922 |
| SECONDARY Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score |
4.48; 6.68 | 0.005 sig |
| SECONDARY Change From Baseline to Month 6 in KCCQ Symptom Frequency Score |
3.91; 6.20 | 0.011 sig |
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 heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.
Eligibility Criteria
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) 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)
Data sourced from ClinicalTrials.gov (NCT00358215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.