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

Heart Failure Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358215
• Other study ID #: 20050222
• Secondary ID: RED-HF™ Trial
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2006
• Est. completion date: October 11, 2012

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2278
• Est. completion date: October 11, 2012
• Est. primary completion date: October 11, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Cardiovascular Disease
• Cardiovascular Diseases
• Congestive Heart Failure
• Heart Failure
• Ventricular Dysfunction

Intervention

Drug:
• Darbepoetin alfa
Administered by subcutaneous injection
• Placebo
Placebo subcutaneous injection

Locations

Country	Name	City	State
Argentina	Research Site	Adrogue	Buenos Aires
Argentina	Research Site	Bahia Blanca	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Capital Federal
Argentina	Research Site	Capital Federal	Buenos Aires
Argentina	Research Site	Capital Federal	Buenos Aires
Argentina	Research Site	Cipolletti	RÃ-o Negro
Argentina	Research Site	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Cordoba
Argentina	Research Site	Cordoba
Argentina	Research Site	Coronel Suarez	Buenos Aires
Argentina	Research Site	Corrientes
Argentina	Research Site	La Plata	Buenos Aires
Argentina	Research Site	Mar del Plata	Buenos Aires
Argentina	Research Site	Mendoza
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Salta
Argentina	Research Site	San Martin	Buenos Aires
Argentina	Research Site	Santa Fe
Australia	Research Site	Bedford Park	South Australia
Australia	Research Site	Camperdown	New South Wales
Australia	Research Site	Chermside	Queensland
Australia	Research Site	Coffs Harbour	New South Wales
Australia	Research Site	Concord	New South Wales
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Gosford	New South Wales
Australia	Research Site	Heidelberg	Victoria
Australia	Research Site	Kippa Ring	Queensland
Australia	Research Site	Nedlands	Western Australia
Australia	Research Site	New Lambton Heights	New South Wales
Australia	Research Site	Parkville	Victoria
Australia	Research Site	Prahran	Victoria
Australia	Research Site	Randwick	New South Wales
Australia	Research Site	Woolloongabba	Queensland
Austria	Research Site	Innsbruck
Austria	Research Site	Linz
Austria	Research Site	Linz
Austria	Research Site	Salzburg
Austria	Research Site	Wels
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Aalst
Belgium	Research Site	Antwerpen
Belgium	Research Site	Antwerpen
Belgium	Research Site	Bonheiden
Belgium	Research Site	Brugge
Belgium	Research Site	Brussel
Belgium	Research Site	Bruxelles
Belgium	Research Site	Genk
Belgium	Research Site	Gent
Belgium	Research Site	Hasselt
Belgium	Research Site	Huy
Belgium	Research Site	Leuven
Belgium	Research Site	Roeselare
Belgium	Research Site	Turnhout
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Campinas	São Paulo
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Fortaleza	Ceará
Brazil	Research Site	Goiania	Goiás
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Recife	Pernambuco
Brazil	Research Site	Riberão Preto	São Paulo
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Rio De Janeiro
Brazil	Research Site	São José Do Rio Preto	São Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	Salvador	Bahia
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Bulgaria	Research Site	Dimitrovgrad
Bulgaria	Research Site	Haskovo
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Rouse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Veliko Tarnovo
Canada	Research Site	Ajax	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Campbell River	British Columbia
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	North York	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Regina	Saskatchewan
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	St-Jérôme	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
Canada	Research Site	Winnipeg	Manitoba
Chile	Research Site	La Serena	Elqui
Chile	Research Site	Osorno
Chile	Research Site	Rancagua	Cachapoal
Chile	Research Site	San Miguel	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Temuco
Chile	Research Site	Vina del Mar
Czechia	Research Site	Benesov
Czechia	Research Site	Brno
Czechia	Research Site	Ceske Budejovice
Czechia	Research Site	Jihlava
Czechia	Research Site	Karlovy Vary
Czechia	Research Site	Pardubice
Czechia	Research Site	Praha 1
Czechia	Research Site	Praha 10
Czechia	Research Site	Praha 10
Czechia	Research Site	Praha 2
Czechia	Research Site	Praha 2
Czechia	Research Site	Pribram 8
Czechia	Research Site	Tabor
Czechia	Research Site	Usti nad Labem
Denmark	Research Site	Fredericia
Denmark	Research Site	Frederiksberg
Denmark	Research Site	Frederikshavn
Denmark	Research Site	Glostrup
Denmark	Research Site	Hellerup
Denmark	Research Site	Herlev
Denmark	Research Site	Horsens
Denmark	Research Site	Hvidovre
Denmark	Research Site	København Ø
Denmark	Research Site	København S
Denmark	Research Site	Køge
Denmark	Research Site	Odense
Denmark	Research Site	Roskilde
Denmark	Research Site	Svendborg
Estonia	Research Site	Pärnu
Estonia	Research Site	Tallinn
Estonia	Research Site	Tallinn
Estonia	Research Site	Tallinn
Finland	Research Site	Espoo
Finland	Research Site	Helsinki
Finland	Research Site	Lahti
Finland	Research Site	Seinajoki
France	Research Site	Bron
France	Research Site	Caen Cedex 14
France	Research Site	Cholet Cedex
France	Research Site	Créteil Cedex
France	Research Site	Douai Cedex
France	Research Site	Grenoble Cedex 9
France	Research Site	Lille Cedex
France	Research Site	Montfermeil
France	Research Site	Montpellier cedex 05
France	Research Site	Nice Cedex 01
France	Research Site	Paris
France	Research Site	Paris Cedex 13
France	Research Site	Pessac Cedex
France	Research Site	Poitiers
France	Research Site	Pontoise Cedex
France	Research Site	Rouen Cedex
France	Research Site	Saint Herblain
France	Research Site	Strasbourg
France	Research Site	Toulouse Cedex 09
France	Research Site	Vandoeuvre-les-Nancy
Germany	Research Site	Bad Tölz
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Bremen
Germany	Research Site	Frankfurt
Germany	Research Site	Göttingen
Germany	Research Site	Georgsmarienhütte
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Heidelberg
Germany	Research Site	Heidelberg
Germany	Research Site	Homburg
Germany	Research Site	Ingelheim
Germany	Research Site	Köln
Germany	Research Site	Lahr
Germany	Research Site	Leipzig
Germany	Research Site	Mainz
Germany	Research Site	Marburg
Germany	Research Site	Nürnberg
Germany	Research Site	Schwedt
Germany	Research Site	Stuttgart
Germany	Research Site	Witten
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	New Territories
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyor
Hungary	Research Site	Kalocsa
Hungary	Research Site	Kecskemet
Hungary	Research Site	Sopron
Hungary	Research Site	Szeged
Hungary	Research Site	Szekesfehervar
Hungary	Research Site	Szekszard
Hungary	Research Site	Szolnok
Hungary	Research Site	Veszprem
Hungary	Research Site	Zalaegerszeg
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Bangalore	Karnataka
India	Research Site	Bangalore	Karnataka
India	Research Site	Bikaner	Rajasthan
India	Research Site	Chennai	Tamil Nadu
India	Research Site	Chennai	Tamil Nadu
India	Research Site	Chennai	Tamil Nadu
India	Research Site	Coimbatore	Tamil Nadu
India	Research Site	Coimbatore	Tamil Nadu
India	Research Site	Gurgaon	Haryana
India	Research Site	Hyderabad	Andhra Pradesh
India	Research Site	Hyderabad	Andhra Pradesh
India	Research Site	Hyderabad	Andhra Pradesh
India	Research Site	Lucknow	Uttar Pradesh
India	Research Site	Ludhiana	Punjab
India	Research Site	Madurai	Tamil Nadu
India	Research Site	Mumbai	Maharashtra
India	Research Site	Mumbai
India	Research Site	Nagpur	Maharashtra
India	Research Site	Nashik	Maharashtra
India	Research Site	New Delhi	Delhi
India	Research Site	New Delhi	Delhi
India	Research Site	Pune	Maharashtra
India	Research Site	Pune	Maharashtra
India	Research Site	Pune	Maharashtra
India	Research Site	Pune	Maharashtra
India	Research Site	Pune	Maharashtra
India	Research Site	Pune	Maharashtra
Israel	Research Site	Askelon
Israel	Research Site	Beer Sheva
Israel	Research Site	Beer Yaakov
Israel	Research Site	Givatayim
Israel	Research Site	Hadera
Israel	Research Site	Haifa
Israel	Research Site	Holon
Israel	Research Site	Jerusalem
Israel	Research Site	Jerusalem
Israel	Research Site	Kfar Saba
Israel	Research Site	Safed
Israel	Research Site	Tel-Aviv
Italy	Research Site	Arezzo
Italy	Research Site	Bergamo
Italy	Research Site	Cesenatico (FC)
Italy	Research Site	Cetraro CS
Italy	Research Site	Cortona AR
Italy	Research Site	Eboli
Italy	Research Site	Ferrara
Italy	Research Site	Forlì
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Oliveto Citra SA
Italy	Research Site	Palermo
Italy	Research Site	Palmanova UD
Italy	Research Site	Pavia
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Rozzano MI
Italy	Research Site	San Bonifacio VR
Italy	Research Site	Torino
Italy	Research Site	Trento
Italy	Research Site	Udine
Latvia	Research Site	Daugavpils
Latvia	Research Site	Ogre
Latvia	Research Site	Rezekne
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Lithuania	Research Site	Alytus
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Klaipeda
Lithuania	Research Site	Siauliai
Lithuania	Research Site	Vilnius
Lithuania	Research Site	Vilnius
Lithuania	Research Site	Vilnius
Lithuania	Research Site	Vilnius
Mexico	Research Site	Baja California
Mexico	Research Site	Distrito Federal
Mexico	Research Site	Guadajalara	Jalisco
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Merida	Yucatán
Mexico	Research Site	Mexico City	Distrito Federal
Mexico	Research Site	Monterrey	Nuevo León
Mexico	Research Site	San Luis Potosi	San Luis PotosÃ-
Mexico	Research Site	Xalapa	Veracruz
Netherlands	Research Site	's Hertogenbosch
Netherlands	Research Site	Alkmaar
Netherlands	Research Site	Almelo
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Arnhem
Netherlands	Research Site	Assen
Netherlands	Research Site	Blaricum
Netherlands	Research Site	Breda
Netherlands	Research Site	Delft
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Deventer
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Enschede
Netherlands	Research Site	Groningen
Netherlands	Research Site	Haarlem
Netherlands	Research Site	Harderwijk
Netherlands	Research Site	Heerlen
Netherlands	Research Site	Hilversum
Netherlands	Research Site	Hoorn
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Sneek
Netherlands	Research Site	Tiel
Netherlands	Research Site	Tilburg
Netherlands	Research Site	Zwijndrecht
Norway	Research Site	Ã…lesund
Norway	Research Site	Arendal
Norway	Research Site	Gjettum
Norway	Research Site	Kristiansand
Norway	Research Site	Oslo
Norway	Research Site	Skien
Norway	Research Site	Stavanger
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Gdynia
Poland	Research Site	Gdynia
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Krakow
Poland	Research Site	Lublin
Poland	Research Site	Stalowa Wola
Poland	Research Site	Tarnow
Poland	Research Site	Walbrzych
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Zabrze
Poland	Research Site	Zielona Gora
Portugal	Research Site	Coimbra
Portugal	Research Site	Faro
Portugal	Research Site	Lisboa
Portugal	Research Site	Lisbon
Puerto Rico	Research Site	San Juan
Romania	Research Site	Arad
Romania	Research Site	Bacau
Romania	Research Site	Brasov
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Iasi
Romania	Research Site	Oradea
Romania	Research Site	Sibiu
Romania	Research Site	Targu Mures
Romania	Research Site	Targu Mures
Romania	Research Site	Timisoara
Romania	Research Site	Timisoara
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Sankt-Petersburg
Russian Federation	Research Site	St Petersburg
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Volgograd
Slovakia	Research Site	Bardejov
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice
Slovakia	Research Site	Levice
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Nitra
Slovakia	Research Site	Nitra
Slovakia	Research Site	Presov
Slovakia	Research Site	Zilina
South Africa	Research Site	Boksburg	Gauteng
South Africa	Research Site	Cape Town
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban	KwaZulu-Natal
South Africa	Research Site	Durban	KwaZulu-Natal
South Africa	Research Site	Durban	KwaZulu-Natal
South Africa	Research Site	Johannesburg	Gauteng
South Africa	Research Site	Johannesburg	Gauteng
South Africa	Research Site	Parow	Western Cape
South Africa	Research Site	Pretoria	Gauteng
South Africa	Research Site	Somerset West	Western Cape
South Africa	Research Site	Soweto	Gauteng
South Africa	Research Site	Worcester	Western Cape
Spain	Research Site	Badalona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Córdoba	AndalucÃ-a
Spain	Research Site	El Palmar	Murcia
Spain	Research Site	Galdakao	PaÃ-s Vasco
Spain	Research Site	Granada	AndalucÃ-a
Spain	Research Site	Málaga	AndalucÃ-a
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Majadhonda	Madrid
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Sabadell	Cataluña
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Santiago de Compostela	Galicia
Spain	Research Site	Tarragona	Cataluña
Spain	Research Site	Valencia	Comunidad Valenciana
Sweden	Research Site	Ã-rebro
Sweden	Research Site	Danderyd
Sweden	Research Site	Göteborg
Sweden	Research Site	Göteborg
Sweden	Research Site	Linköping
Sweden	Research Site	Mölndal
Sweden	Research Site	Malmö
Sweden	Research Site	Stockholm
Sweden	Research Site	Sundsvall
Sweden	Research Site	Umeå
Sweden	Research Site	Uppsala
Switzerland	Research Site	Lugano
Switzerland	Research Site	St. Gallen
United Kingdom	Research Site	Barnet
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Bradford
United Kingdom	Research Site	Bridlington
United Kingdom	Research Site	Cottingham
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Harrow
United Kingdom	Research Site	Kirkcaldy
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Livingston
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Romford
United Kingdom	Research Site	Stockport
United Kingdom	Research Site	Worcester
United Kingdom	Research Site	Worthing
United Kingdom	Research Site	York
United States	Research Site	Akron	Ohio
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Alexandria	Louisiana
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Anaheim	California
United States	Research Site	Anderson	Indiana
United States	Research Site	Anderson	South Carolina
United States	Research Site	Annandale	Virginia
United States	Research Site	Annapolis	Maryland
United States	Research Site	Asheville	North Carolina
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Augusta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Ayer	Massachusetts
United States	Research Site	Baltimore	Maryland
United States	Research Site	Beaumont	Texas
United States	Research Site	Bellingham	Washington
United States	Research Site	Beloit	Wisconsin
United States	Research Site	Bend	Oregon
United States	Research Site	Birmingham	Alabama
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bridgeport	Connecticut
United States	Research Site	Bronx	New York
United States	Research Site	Bronx	New York
United States	Research Site	Buena Park	California
United States	Research Site	Buffalo	New York
United States	Research Site	Burlington	North Carolina
United States	Research Site	Canton	Ohio
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	Missouri
United States	Research Site	Columbia	South Carolina
United States	Research Site	Corona	California
United States	Research Site	Cortlandt Manor	New York
United States	Research Site	Covington	Louisiana
United States	Research Site	Covington	Georgia
United States	Research Site	Culver City	California
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Des Moines	Iowa
United States	Research Site	Detroit	Michigan
United States	Research Site	Detroit	Michigan
United States	Research Site	Downey	California
United States	Research Site	Duluth	Minnesota
United States	Research Site	Durham	North Carolina
United States	Research Site	Elk Grove Village	Illinois
United States	Research Site	Evanston	Illinois
United States	Research Site	Fairfield	Connecticut
United States	Research Site	Flushing	New York
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Galveston	Texas
United States	Research Site	Garden City	New York
United States	Research Site	Garfield Heights	Ohio
United States	Research Site	Gastonia	North Carolina
United States	Research Site	Germantown	Tennessee
United States	Research Site	Gilbert	Arizona
United States	Research Site	Grand Island	Nebraska
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Hackensack	New Jersey
United States	Research Site	Haverhill	Massachusetts
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Hillsboro	Oregon
United States	Research Site	Hinsdale	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Iowa City	Iowa
United States	Research Site	Iowa City	Iowa
United States	Research Site	Jackson	Tennessee
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville Beach	Florida
United States	Research Site	Jeffersonville	Indiana
United States	Research Site	Johnson City	New York
United States	Research Site	Jupiter	Florida
United States	Research Site	Kalispell	Montana
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kansas City	Kansas
United States	Research Site	Kingston	New York
United States	Research Site	Kirkland	Washington
United States	Research Site	La Jolla	California
United States	Research Site	Lake Charles	Louisiana
United States	Research Site	Lancaster	California
United States	Research Site	Lancaster	Pennsylvania
United States	Research Site	Lansing	Michigan
United States	Research Site	Larkspur	California
United States	Research Site	Lebanon	New Hampshire
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Littleton	Colorado
United States	Research Site	Loma Linda	California
United States	Research Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Louisville	Kentucky
United States	Research Site	Loveland	Colorado
United States	Research Site	Lubbock	Texas
United States	Research Site	Madison	Wisconsin
United States	Research Site	Madison	Wisconsin
United States	Research Site	Madisonville	Kentucky
United States	Research Site	Marrero	Louisiana
United States	Research Site	Mayfield Heights	Ohio
United States	Research Site	Maywood	Illinois
United States	Research Site	Melbourne	Florida
United States	Research Site	Melrose Park	Illinois
United States	Research Site	Memphis	Tennessee
United States	Research Site	Memphis	Tennessee
United States	Research Site	Meridian	Idaho
United States	Research Site	Mesa	Arizona
United States	Research Site	Miami	Florida
United States	Research Site	Miami Beach	Florida
United States	Research Site	Midlothian	Virginia
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Missoula	Montana
United States	Research Site	Mobile	Alabama
United States	Research Site	Modesto	California
United States	Research Site	Morristown	New Jersey
United States	Research Site	Muskegon	Michigan
United States	Research Site	Nashville	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	Natick	Massachusetts
United States	Research Site	New Bern	North Carolina
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Newark	New Jersey
United States	Research Site	Newark	New Jersey
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	Oak Lawn	Illinois
United States	Research Site	Oakbrook Terrace	Illinois
United States	Research Site	Oakland	California
United States	Research Site	Odessa	Texas
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Olathe	Kansas
United States	Research Site	Orangeburg	South Carolina
United States	Research Site	Orlando	Florida
United States	Research Site	Pasadena	California
United States	Research Site	Pawtucket	Rhode Island
United States	Research Site	Peoria	Illinois
United States	Research Site	Petoskey	Michigan
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Port Charlotte	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Redondo Beach	California
United States	Research Site	Richmond	Virginia
United States	Research Site	Roanoke	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Rockford	Illinois
United States	Research Site	Rome	Georgia
United States	Research Site	Sacramento	California
United States	Research Site	Sacramento	California
United States	Research Site	Safety Harbor	Florida
United States	Research Site	Saginaw	Michigan
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis Park	Minnesota
United States	Research Site	Saint Paul	Minnesota
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Salisbury	Maryland
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Francisco	California
United States	Research Site	San Francisco	California
United States	Research Site	Sandusky	Ohio
United States	Research Site	Santa Monica	California
United States	Research Site	Santa Rosa	California
United States	Research Site	Sarasota	Florida
United States	Research Site	Sayre	Pennsylvania
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Seattle	Washington
United States	Research Site	Slidell	Louisiana
United States	Research Site	South Portland	Maine
United States	Research Site	Southfield	Michigan
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Springfield	Illinois
United States	Research Site	Springfield	Illinois
United States	Research Site	Staten Island	New York
United States	Research Site	Summit	New Jersey
United States	Research Site	Sylmar	California
United States	Research Site	Syracuse	New York
United States	Research Site	Tacoma	Washington
United States	Research Site	Tamarac	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Toledo	Ohio
United States	Research Site	Troy	New York
United States	Research Site	Tucson	Arizona
United States	Research Site	Tullahoma	Tennessee
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Tyler	Texas
United States	Research Site	Valparaiso	Indiana
United States	Research Site	Walnut Creek	California
United States	Research Site	Washington	District of Columbia
United States	Research Site	Washington	District of Columbia
United States	Research Site	West Islip	New York
United States	Research Site	West Roxbury	Massachusetts
United States	Research Site	Westlake Village	California
United States	Research Site	Westwood	New Jersey
United States	Research Site	Whitman	Massachusetts
United States	Research Site	Wichita	Kansas
United States	Research Site	Williamsville	New York
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Worcester	Massachusetts
United States	Research Site	Worcester	Massachusetts
United States	Research Site	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Latvia,  Lithuania,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (2)

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. Erratum in: Eur J Heart Fail. 2010 Jul;12(7):765. Pouler, A C [corrected to Pouleur, A C]. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to All Cause Death or First Hospitalization for Worsening Heart Failure	Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.	From randomization to the end of study; maximum time on study was 73 months
Secondary	Time to Death From Any Cause	Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.	From randomization to the end of study; maximum time on study was 73 months
Secondary	Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure	Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.	From randomization to the end of study; maximum time on study was 73 months
Secondary	Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.	Baseline and Month 6
Secondary	Change From Baseline to Month 6 in KCCQ Symptom Frequency Score	The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.	Baseline and Month 6

External Links

•   AmgenTrials clinical trials website