Transcript RED-HF Trial - Duke University

RED-HF Trial
Reduction of Events with Darbepoetin alfa in Heart
Failure Trial
Duke Heart Failure Research
Pager: 970-0736
Purpose

Assess efficacy and safety of Darbepoetin
alfa treatment on mortality and morbidity
in heart failure subjects with symptomatic
left ventricular systolic dysfunction and
anemia
Darbepoetin alfa – glycoprotein that stimulates erythropoietin,
a hormone released from the kidney that develops red blood
cells and produces hemoglobin
Inclusion Criteria

EF ≤ 40%

HF ≥ 3 months
& NYHA class II, III, or IV at randomization
• ≥18 years old
● Hemoglobin ≥9
and ≤12 g/dL
● On stable medical
therapy
Interventions
Randomization 1:1
Darbepoetin
alfa
SC injection
Placebo
SC injection
Nursing Roles

If an enrolled subject is admitted to the hospital,
please notify the research team (970-0736) so
that the study drug can be obtained and
administrated at the appropriate time.

Side effects of Darbepoetin alfa (See Adverse
Reactions List):
http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnu
m=2571&sec=monadve
Outcomes

Why is this study being done?
 To
compare the efficacy of Darbepoetin alfa
to placebo as measured by the time to:
 1st
hospital admission for worsening HF or
 death