RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
- Conditions
- Heart Failure Subjects with Symptomatic Left Ventricular Systolic Dysfunction and AnemiaMedDRA version: 14.0Level: PTClassification code 10007559Term: Cardiac failure congestiveSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2005-005278-59-BE
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2600
Before any study-specific procedure, the appropriate written informed consent must be obtained.
= 18 years of age at the time of randomization.
Heart failure = 3 months, and of NYHA class II, III, and IV at the time of randomisation.
Left ventricular ejection fraction = 40% by echocardiogram, radionuclide ventriculography, cardiac magnetic resonance imaging, or X-ray contrast ventriculography within 6 months prior to randomization. For patients with CRT, LVEF assessment for eligibility must be performed at least 3 months after device implantation.
Hemoglobin concentration must be = 9.0 g/dL and = 12.0 g/dL (average of 2 hemoglobin concentrations as measured by blinded [coded] HemoCue® analyzer).
Treated for HF with stable, optimal pharmacological therapy. In general, optimal treatment will include a beta-blocker and an ACE inhibitor and/or an ARB at doses shown to be efficacious in HF trials, unless not tolerated. Stable medical therapy is defined as having no new HF drug class introduced 4 weeks prior to randomization, although doses of all drugs being received may be adjusted throughout the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000
Poorly controlled hypertension, defined as blood pressure > 160/100 mm Hg assessed on two separate occasions prior to randomization.
Serum creatinine > 3.0 mg/dL (> 265 µmol/L)
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.
Implantable cardioverter defibrillator (ICD) within 30 days prior to randomization or initiation of cardiac resynchronization therapy (CRT with/without ICD) within 3 months prior to randomization.
Routinely scheduled IV infusions for HF (eg, inotropes, vasodilators [eg, nesiritide], diuretics).
Acute myocardial infarction or cerebrovascular accident within 3 months prior to randomization.
Percutaneous intervention (cardiac, cerebrovascular, aortic) within 8 weeks prior to randomization. Major surgery, including thoracic or cardiac surgery, within 3 months prior to randomization.
Symptomatic tachyarrhythmia with an uncontrolled ventricular response (> 100 bpm at rest) or an untreated symptomatic bradyarrhythmia within 1 month prior to randomization.
Hypertrophic obstructive cardiomyopathy, active myocarditis, or constrictive pericarditis.
Likely to receive cardiac transplant within 12 months after randomization.
Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow) or receiving renal replacement therapy.
Anemia that is due to acute or chronic bleeding.
Transferrin saturation (Tsat) < 15% at the time of screening (value rounded to the nearest full percentage point).
Serum vitamin B12 or folate level below the lower limit of normal.
Whole blood or red blood cell (RBC) transfusion within 8 weeks prior to randomization.
Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years.
Receiving or has received chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months prior to randomization or clinical evidence of current malignancy, with the following exceptions: localized basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
Known active systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia), hemolysis due to any cause, thalassemia.
Untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease.
Use of any erythropoietic protein (eg, rHuEPO) within 12 weeks prior to randomization.
Known hypersensitivity to any of the products to be administered during the study, including oral or IV iron.
Subject is pregnant (eg, positive human chorionic gonadotropin [HCG] test), is breast feeding, or is of child-bearing potential and not using adequate contraceptive precautions.
Currently enrolled in, or at least 30 days not yet elapsed since ending participation in other investigational device or drug trial(s) or receiving other investigational agent(s) or procedure(s).
Subject has a disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: To evaluate the effects of treatment with darbepoetin alfa on <br>• Time to death from any cause. <br>• Time to cardiovascular death or first hospital admission for worsening HF, whichever occurs first. <br>• Change from baseline to month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. <br>• Change from baseline to month 6 in KCCQ Symptom Frequency Score.;Primary end point(s): Time to death from any cause or first hospital admission for worsening HF, whichever is first.<br><br>;Timepoint(s) of evaluation of this end point: Ongoing as each event occurs
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Time to death from any cause<br>• Time to cardiovascular death or first hospital admission for worsening HF, whichever occurs<br>first<br>• Change from baseline to month 6 in KCCQ Overall Summary Score<br>• Change from baseline to month 6 in KCCQ Symptom Frequency Score;Timepoint(s) of evaluation of this end point: Ongoing as each event occurs<br><br>KCCQ performed at W1, M3, M6, M9, M12, M18, M24, M30, M36, M42, M48, M54, EOS/EOT<br><br><br>