Clinical trial NCT00358215: RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Anemia
Cardiovascular Disease
Ventricular Dysfunction
Congestive Heart Failure
Keywords: Survival study
morbidity and mortality
heart failure hospitalization
all-cause death
patient-reported outcomes
Kansas City Cardiomyopathy questionnaire
anemia treatment
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-07-31
Enrollment: 2278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.

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 patients 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 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)

Primary outcomes:
measure: Time to All Cause Death or First Hospitalization for Worsening Heart Failure
timeFrame: From randomization to the end of study; maximum time on study was 73 months
Secondary outcomes:
measure: Time to Death From Any Cause
timeFrame: From randomization to the end of study; maximum time on study was 73 months
measure: Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure
timeFrame: From randomization to the end of study; maximum time on study was 73 months
measure: Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
timeFrame: Baseline and Month 6
measure: Change From Baseline to Month 6 in KCCQ Symptom Frequency Score
timeFrame: Baseline and Month 6
Other outcomes:
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facility: Research Site
city: CÃ³rdoba
country: Spain
facility: Research Site
state: AndalucÃ-a
city: Granada
country: Spain
facility: Research Site
state: AndalucÃ-a
city: MÃ¡laga
country: Spain
facility: Research Site
state: AndalucÃ-a
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Badalona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Sabadell
country: Spain
facility: Research Site
state: CataluÃ±a
city: Tarragona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Galicia
city: Majadhonda
country: Spain
facility: Research Site
state: Madrid
city: El Palmar
country: Spain
facility: Research Site
state: Murcia
city: Galdakao
country: Spain
facility: Research Site
state: PaÃ-s Vasco
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Danderyd
country: Sweden
facility: Research Site
city: GÃ¶teborg
country: Sweden
facility: Research Site
city: GÃ¶teborg
country: Sweden
facility: Research Site
city: LinkÃ¶ping
country: Sweden
facility: Research Site
city: MalmÃ¶
country: Sweden
facility: Research Site
city: MÃ¶lndal
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sundsvall
country: Sweden
facility: Research Site
city: UmeÃ¥
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Ã-rebro
country: Sweden
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Barnet
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Bridlington
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: Kirkcaldy
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Livingston
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Romford
country: United Kingdom
facility: Research Site
city: Stockport
country: United Kingdom
facility: Research Site
city: Worcester
country: United Kingdom
facility: Research Site
city: Worthing
country: United Kingdom
facility: Research Site
city: York
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801. doi: 10.1093/eurjhf/hfp098.
citation: Swedberg K, Young JB, Anand IS, Cheng S, Desai AS, Diaz R, Maggioni AP, McMurray JJ, O'Connor C, Pfeffer MA, Solomon SD, Sun Y, Tendera M, van Veldhuisen DJ; RED-HF Committees; RED-HF Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. 2013 Mar 28;368(13):1210-9. doi: 10.1056/NEJMoa1214865. Epub 2013 Mar 10.
citation: Abraityte A, Aukrust P, Kou L, Anand IS, Young J, Mcmurray JJV, van Veldhuisen DJ, Gullestad L, Ueland T. T cell and monocyte/macrophage activation markers associate with adverse outcome, but give limited prognostic value in anemic patients with heart failure: results from RED-HF. Clin Res Cardiol. 2019 Feb;108(2):133-141. doi: 10.1007/s00392-018-1331-2. Epub 2018 Jul 26.
citation: van der Meer P, Grote Beverborg N, Pfeffer MA, Olson K, Anand IS, Westenbrink BD, McMurray JJV, Swedberg K, Young JB, Solomon SD, van Veldhuisen DJ. Hyporesponsiveness to Darbepoetin Alfa in Patients With Heart Failure and Anemia in the RED-HF Study (Reduction of Events by Darbepoetin Alfa in Heart Failure): Clinical and Prognostic Associations. Circ Heart Fail. 2018 Feb;11(2):e004431. doi: 10.1161/CIRCHEARTFAILURE.117.004431.