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

NCT ID: NCT00358215

Last Updated: 2022-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-01

Study Completion Date

2012-10-11

Brief Summary

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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

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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.

Conditions

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Heart Failure Anemia Cardiovascular Disease Ventricular Dysfunction Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Darbepoetin alfa

Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.

Group Type EXPERIMENTAL

Darbepoetin alfa

Intervention Type DRUG

Administered by subcutaneous injection

Placebo

Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo subcutaneous injection

Interventions

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Darbepoetin alfa

Administered by subcutaneous injection

Intervention Type DRUG

Placebo

Placebo subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Aranesp®

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Gilbert, Arizona, United States

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Mesa, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Buena Park, California, United States

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Corona, California, United States

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Culver City, California, United States

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Downey, California, United States

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La Jolla, California, United States

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Lancaster, California, United States

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Larkspur, California, United States

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Loma Linda, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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Oakland, California, United States

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Pasadena, California, United States

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Redondo Beach, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Santa Monica, California, United States

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Santa Rosa, California, United States

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Sylmar, California, United States

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Walnut Creek, California, United States

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Westlake Village, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Littleton, Colorado, United States

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Loveland, Colorado, United States

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Bridgeport, Connecticut, United States

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Fairfield, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville Beach, Florida, United States

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Jupiter, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Port Charlotte, Florida, United States

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Safety Harbor, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Covington, Georgia, United States

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Rome, Georgia, United States

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Meridian, Idaho, United States

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Chicago, Illinois, United States

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Elk Grove Village, Illinois, United States

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Evanston, Illinois, United States

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Hinsdale, Illinois, United States

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Maywood, Illinois, United States

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Melrose Park, Illinois, United States

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Oak Lawn, Illinois, United States

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Oakbrook Terrace, Illinois, United States

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Peoria, Illinois, United States

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Rockford, Illinois, United States

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Springfield, Illinois, United States

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Anderson, Indiana, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Jeffersonville, Indiana, United States

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Valparaiso, Indiana, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Olathe, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Alexandria, Louisiana, United States

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Covington, Louisiana, United States

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Lake Charles, Louisiana, United States

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Marrero, Louisiana, United States

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Slidell, Louisiana, United States

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South Portland, Maine, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Salisbury, Maryland, United States

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Ayer, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Haverhill, Massachusetts, United States

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Natick, Massachusetts, United States

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West Roxbury, Massachusetts, United States

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Whitman, Massachusetts, United States

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Worcester, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Lansing, Michigan, United States

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Muskegon, Michigan, United States

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Petoskey, Michigan, United States

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Saginaw, Michigan, United States

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Southfield, Michigan, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Saint Paul, Minnesota, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Grand Island, Nebraska, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Lebanon, New Hampshire, United States

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Hackensack, New Jersey, United States

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Morristown, New Jersey, United States

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Newark, New Jersey, United States

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Newark, New Jersey, United States

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Summit, New Jersey, United States

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Westwood, New Jersey, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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Cortlandt Manor, New York, United States

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Flushing, New York, United States

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Garden City, New York, United States

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Johnson City, New York, United States

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Kingston, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Troy, New York, United States

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West Islip, New York, United States

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Williamsville, New York, United States

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Asheville, North Carolina, United States

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Burlington, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Gastonia, North Carolina, United States

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Greensboro, North Carolina, United States

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New Bern, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Garfield Heights, Ohio, United States

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Mayfield Heights, Ohio, United States

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Sandusky, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Bend, Oregon, United States

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Hillsboro, Oregon, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Orangeburg, South Carolina, United States

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Spartanburg, South Carolina, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Tullahoma, Tennessee, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Odessa, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Annandale, Virginia, United States

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Midlothian, Virginia, United States

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Richmond, Virginia, United States

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Roanoke, Virginia, United States

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Bellingham, Washington, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Beloit, Wisconsin, United States

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Madison, Wisconsin, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Adrogué, Buenos Aires, Argentina

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Bahía Blanca, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Coronel Suárez, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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San Martín, Buenos Aires, Argentina

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Córdoba, Córdoba, Argentina

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Cipolletti, RÃ-o Negro, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Capital Federal, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Mendoza, , Argentina

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Salta, , Argentina

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Santa Fe, , Argentina

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Camperdown, New South Wales, Australia

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Coffs Harbour, New South Wales, Australia

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Concord, New South Wales, Australia

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Gosford, New South Wales, Australia

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New Lambton Heights, New South Wales, Australia

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Randwick, New South Wales, Australia

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Chermside, Queensland, Australia

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Kippa-Ring, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Bedford Park, South Australia, Australia

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Geelong, Victoria, Australia

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Heidelberg, Victoria, Australia

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Parkville, Victoria, Australia

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Prahran, Victoria, Australia

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Nedlands, Western Australia, Australia

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Innsbruck, , Austria

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Linz, , Austria

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Linz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Wels, , Austria

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Aalst, , Belgium

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Antwerp, , Belgium

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Antwerp, , Belgium

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Bonheiden, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Genk, , Belgium

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Ghent, , Belgium

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Huy, , Belgium

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Leuven, , Belgium

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Roeselare, , Belgium

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Turnhout, , Belgium

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Fortaleza, Ceará, Brazil

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Salvador, Estado de Bahia, Brazil

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Goiânia, Goiás, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Recife, Pernambuco, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Rio de Janeiro, , Brazil

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Rio de Janeiro, , Brazil

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Rio de Janeiro, , Brazil

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Dimitrovgrad, , Bulgaria

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Haskovo, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Veliko Tarnovo, , Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Campbell River, British Columbia, Canada

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Regina, Saskatchewan, Canada

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Rancagua, Cachapoal, Chile

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La Serena, Elqui, Chile

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San Miguel, Santiago Metropolitan, Chile

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Osorno, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Temuco, , Chile

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Viña del Mar, , Chile

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Benešov, , Czechia

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Brno, , Czechia

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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 Russia Slovakia South Africa Spain Sweden Switzerland United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 19633103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23473338 (View on PubMed)

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Reference Type DERIVED
PMID: 36791280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30051179 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29367268 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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RED-HF™ Trial

Identifier Type: -

Identifier Source: secondary_id

20050222

Identifier Type: -

Identifier Source: org_study_id

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