RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
Heart Failure, Anemia, Cardiovascular Disease
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Survival study, morbidity and mortality, heart failure hospitalization, all-cause death, patient-reported outcomes, Kansas City Cardiomyopathy questionnaire, anemia treatment
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) < 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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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Darbepoetin alfa
Placebo
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.
Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.