RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00358215

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 III

MedlinePlus related topics: Anemia Cardiomyopathy Heart Failure

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	2600
Study Start Date:	June 2006
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental	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: Placebo Comparator	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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358215

Contacts

Contact: Amgen Call Center

866-572-6436

Show 588 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050222, RED-HF™ Trial
Study First Received:	July 27, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00358215
Health Authority:	Chile: Health Ministry; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Estonia: State Agency of Medicines; Finland: Lääkelaitos; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; Ireland: Irish Medicines Board (IMB); Israel: Ministry of Health; Italy: Local Ethics Committees; Lithuania: State Medicines Control Agency of Lithuania; Latvia: State Agency of Medicines; Mexico: Ministry of Health; Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research; Norway: Norwegian Medicines Agency; 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); Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; 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; United States: Food and Drug Administration; Belgium: Federal Public Service; Brazil: ANVISA (Agência Nacional de Vigilância Sanitária); Bulgaria: Bulgarian Drug Agency; Bulgaria: Ministry of Health; Canada: Health Canada

Keywords provided by Amgen:

Survival study
morbidity and mortality
heart failure hospitalization
all-cause death

patient-reported outcomes
Kansas City Cardiomyopathy questionnaire
anemia treatment

Study placed in the following topic categories:

Ventricular Dysfunction
Death
Heart Failure
Heart Diseases

Hematologic Diseases
Darbepoetin alfa
Anemia
Cardiomyopathies

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009