RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Anemia Cardiovascular Disease Ventricular Dysfunction Congestive Heart Failure |
Drug: Darbepoetin alfa Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A 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 |
- 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 ]
- 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 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 change from baseline to month 6 in KCCQ Symptom Frequency Score [ Time Frame: Six months ] [ Designated as safety issue: No ]
| Enrollment: | 2278 |
| Study Start Date: | June 2006 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active |
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 |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo group to receive volume and dose frequency changes resembling titration dosing in the treatment group
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Show 755 Study Locations| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00358215 History of Changes |
| Other Study ID Numbers: | 20050222, RED-HF™ Trial |
| Study First Received: | July 27, 2006 |
| Last Updated: | January 24, 2013 |
| Health Authority: | Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica) Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information Belgium: Federal Public Service Brazil: ANVISA (Agência Nacional de Vigilância Sanitária) Bulgaria: Bulgarian Drug Agency Bulgaria: Ministry of Health Canada: Health Canada Chile: Health Ministry Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Estonia: State Agency of Medicines Finland: Lääkelaitos France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Hungary: National Institute of Pharmacy India: Central Drugs Standard Control Organization Ireland: Irish Medicines Board (IMB) Israel: Ministry of Health Italy: Local Ethics Committees Latvia: State Agency of Medicines Lithuania: State Medicines Control Agency of Lithuania Mexico: Ministry of Health Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research Norway: Norwegian Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED) Romania: Romanian National Drug Agency Russia: Ministry of Health Slovakia: Štátny ústav pre kontrolu lieciv Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Switzerland: Swissmedic (Swiss Agency for Therapeutic Products) United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Ukraine: Ministry of Health |
Keywords provided by Amgen:
|
Survival study morbidity and mortality heart failure hospitalization all-cause death |
patient-reported outcomes Kansas City Cardiomyopathy questionnaire anemia treatment |
Additional relevant MeSH terms:
|
Anemia Cardiovascular Diseases Heart Failure Ventricular Dysfunction Hematologic Diseases Heart Diseases |
Darbepoetin alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013