NCT00475852

Brief Summary

The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
7,141

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2007

Typical duration for phase_3

Geographic Reach
28 countries

328 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 10, 2012

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

3.8 years

First QC Date

May 18, 2007

Results QC Date

September 27, 2011

Last Update Submit

March 1, 2013

Conditions

Keywords

Heart DecompensationDyspneaHeart failureNesiritideDecompensatedADHF

Outcome Measures

Primary Outcomes (3)

  • Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality

    Randomization to Day 30

  • Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug

    Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)

    6 hours after initiation of study drug

  • Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug

    Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)

    24 hours after study drug initiation

Secondary Outcomes (5)

  • Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug

    6 hours after study drug initiation

  • Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug

    24 hours after study drug initiation

  • Composite of Persistent or Worsening Heart Failure and All-Cause Mortality

    Randomization to hospital discharge (up to Day 30)

  • Number of Days Alive and Outside the Hospital

    Randomization to Day 30

  • Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality

    Randomization to Day 30

Other Outcomes (4)

  • All-Cause Mortality Through Day 30

    Randomization to Day 30

  • All-Cause Mortality Through Day 180

    Randomization to Day 180

  • Cardiovascular Mortality Through Day 30

    Randomization to Day 30

  • +1 more other outcomes

Study Arms (2)

001

EXPERIMENTAL

Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)

Drug: Nesiritide

002

PLACEBO COMPARATOR

Placebo matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Drug: Placebo

Interventions

0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

001

matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

002

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized for the management of acute decompensated heart failure (ADHF) or diagnosed with ADHF within 48 hours after being hospitalized for another reason; Diagnosis of ADHF is defined as dyspnea (difficulty breathing) at rest or dyspnea with minimal activity.

You may not qualify if:

  • At high risk for hypotension (low blood pressure); Acute coronary syndrome as primary diagnosis; History of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic cardiomyopathy, or pericardial tamponade; Previous enrollment in a nesiritide study; Persistent, uncontrolled hypertension (SBP \[systolic blood pressure\] \>180 mmHg).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (328)

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Anchorage, Alaska, United States

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Gilbert, Arizona, United States

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Scottsdale, Arizona, United States

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Fort Smith, Arkansas, United States

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Jonesboro, Arkansas, United States

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Berkeley, California, United States

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Culver City, California, United States

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Escondido, California, United States

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Inglewood, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Torrance, California, United States

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Ventura, California, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Fort Collins, Colorado, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Newark, Delaware, United States

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

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Inverness, Florida, United States

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Lakeland, Florida, United States

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Melbourne, Florida, United States

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Miami Beach, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Winter Haven, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Gainesville, Georgia, United States

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Macon, Georgia, United States

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Aurora, Illinois, United States

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Chicago, Illinois, United States

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Downers Grove, Illinois, United States

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Elk Grove Village, Illinois, United States

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Hinsdale, Illinois, United States

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La Grange, Illinois, United States

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Maywood, Illinois, United States

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Mokena, 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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Indianapolis, Indiana, United States

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Munster, Indiana, United States

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South Bend, Indiana, United States

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Valparaiso, Indiana, United States

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Danville, Kentucky, United States

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Edgewood, Kentucky, United States

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Lexington, Kentucky, United States

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Owensboro, Kentucky, United States

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Baltimore, Maryland, United States

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Randallstown, Maryland, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Brighton, Massachusetts, United States

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Springfield, Massachusetts, United States

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Worcester, Massachusetts, United States

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Bay City, Michigan, United States

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Detroit, Michigan, United States

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Flint, Michigan, United States

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Lansing, Michigan, United States

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Monroe, Michigan, United States

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Petoskey, Michigan, United States

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Pontiac, Michigan, United States

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Saginaw, Michigan, United States

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Troy, Michigan, United States

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Minneapolis, Minnesota, United States

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Tupelo, Mississippi, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Papillion, Nebraska, United States

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Manchester, New Hampshire, United States

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Browns Mills, New Jersey, United States

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Camden, New Jersey, United States

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Elmer, New Jersey, United States

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Hackensack, New Jersey, United States

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Neptune City, New Jersey, United States

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Newark, New Jersey, United States

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Paterson, New Jersey, United States

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Ridgewood, New Jersey, United States

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Toms River, New Jersey, United States

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Trenton, New Jersey, United States

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Turnersville, New Jersey, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Elmhurst, New York, United States

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Johnson City, New York, United States

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New Hyde Parke, New York, United States

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Poughkeepsie, New York, United States

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Rochester, New York, United States

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Roslyn, New York, United States

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Saratoga Springs, New York, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Asheville, 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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Greenville, 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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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Garfield Heights, Ohio, United States

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Mansfield, Ohio, United States

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Mayfield Heights, Ohio, United States

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Middletown, Ohio, United States

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Sylvania, Ohio, United States

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Toledo, Ohio, United States

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Youngstown, Ohio, United States

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Midwest 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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Abington, Pennsylvania, United States

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Allentown, Pennsylvania, United States

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Beaver, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Natrona Heights, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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York, Pennsylvania, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Greenville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Sumter, South Carolina, United States

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Rapid City, South Dakota, United States

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Kingsport, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Oak Ridge, Tennessee, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Tyler, Texas, United States

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Falls Church, Virginia, United States

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Harrisonburg, Virginia, United States

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Lynchburg, Virginia, United States

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Norfolk, Virginia, United States

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Winchester, Virginia, United States

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Tacoma, Washington, United States

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Burlington, Wisconsin, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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La Plata, Argentina

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Mar del Plata, Argentina

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San Miguel de Tucumán, Argentina

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Santa Fe, Argentina

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Bedford, Australia

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Camperdown, Australia

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Concord, Australia

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Darlinghurst, Australia

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Elizabeth Vale, Australia

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Fitzroy, Australia

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Hobart, Australia

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Kogarah, Australia

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Launceston, Australia

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Melbourne, Australia

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Randwick, Australia

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Belo Horizonte, Brazil

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Campinas, Brazil

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Curitiba, Brazil

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Fortaleza, Brazil

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Goiânia, Brazil

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Porto Alegre, Brazil

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Recife, Brazil

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Rio de Janeiro-Rj, Brazil

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Salvador, Brazil

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São José do Rio Preto, Brazil

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São Paulo, Brazil

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Pleven, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Red Deer, Alberta, Canada

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Campbell River, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Maple Ridge, British Columbia, Canada

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New Westminster, British Columbia, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Lakeland, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Ajax, Ontario, Canada

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Brampton, Ontario, Canada

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Cornwall, Ontario, Canada

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Hamilton, Ontario, Canada

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Kitchener, Ontario, Canada

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Ottawa, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Toronto, Ontario, Canada

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Granby, Quebec, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Terrebonne, Quebec, Canada

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Santiago, Chile

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Santiago Rm, Chile

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Temuco, Chile

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Beijing, China

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Beijing Prc, China

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Guangdong Province, China

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Hangzhou, China

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Jinan, China

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Shanghai, China

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Tianjin, China

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Xi'an, China

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Barranquilla, Colombia

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Bogotá Dc, Colombia

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Floridablanca, Colombia

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Colmar, France

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Paris, France

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Poitiers, France

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Pontoise, France

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Thionville Cedex N/A, France

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Toulouse, France

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Valenciennes, France

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Vandœuvre-lès-Nancy, France

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Bad Krozingen, Germany

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Berlin, Germany

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Brandenburg, Germany

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Ludwigshafen, Germany

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Lüdenscheid, Germany

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Neuruppin, Germany

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Athens, Greece

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Larissa, Greece

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Thessalonikis, Greece

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Volos, Greece

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Ahmedabad, India

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Bengaluru, India

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Coimbatore, India

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Hyderabad, India

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Nagpur, India

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Pune, India

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Vadodara, India

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Hadera, Israel

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Haifa, Israel

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Holon, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Safed, Israel

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Kaunas, Lithuania

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Vilnius Lt, Lithuania

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Johor Bahru, Malaysia

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Kuala Lumpur, Malaysia

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Aguascalientes, Mexico

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Guadalajara, Mexico

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San Luis Potosí City, Mexico

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Sinaloa, Mexico

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Zapopan, Mexico

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Amersfoort, Netherlands

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Delft, Netherlands

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Gorinchem, Netherlands

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Groningen, Netherlands

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Leeuwarden, Netherlands

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Sneek, Netherlands

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Auckland, New Zealand

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Christchurch, New Zealand

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Hamilton, New Zealand

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Hastings, New Zealand

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Lower Hutt, New Zealand

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Nelson, New Zealand

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Stavanger, Norway

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Trondheim, Norway

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Tønsberg, Norway

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Bydgoszcz, Poland

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Gdynia, Poland

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Krakow, Poland

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Ostrowiec Świętokrzyski, Poland

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Skierniewice, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Kemerovo, Russia

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Moscow, Russia

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Tomsk, Russia

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Tyumen, Russia

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Yekaterinburg, Russia

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Singapore, Singapore

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Chungcheongbuk-Do, South Korea

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Seoul, South Korea

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Falun, Sweden

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Uppsala, Sweden

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Kaohsiung City, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Bangkok, Thailand

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Khon Kaen, Thailand

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Dnipro, Ukraine

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Donetsk, Ukraine

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Kharkiv, Ukraine

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Lviv, Ukraine

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Mykolayiv, Ukraine

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Vinnitsa, Ukraine

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Zaporizhzhya, Ukraine

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Related Publications (21)

  • Gui H, Tang WHW, Francke S, Li J, She R, Bazeley P, Pereira NL, Adams K, Luzum JA, Connolly TM, Hernandez AF, McNaughton CD, Williams LK, Lanfear DE. Common Variants on FGD5 Increase Hazard of Mortality or Rehospitalization in Patients With Heart Failure From the ASCEND-HF Trial. Circ Heart Fail. 2023 Sep;16(9):e010438. doi: 10.1161/CIRCHEARTFAILURE.122.010438. Epub 2023 Jul 26.

  • Cosiano MF, Vista A, Sun JL, Alhanti B, Harrington J, Butler J, Starling RC, Mentz RJ, Greene SJ. Comparing New York Heart Association Class and Patient-Reported Outcomes Among Patients Hospitalized for Heart Failure. Circ Heart Fail. 2023 Jan;16(1):e010107. doi: 10.1161/CIRCHEARTFAILURE.122.010107. Epub 2022 Oct 31.

  • Blumer V, Mentz RJ, Sun JL, Butler J, Metra M, Voors AA, Hernandez AF, O'Connor CM, Greene SJ. Prognostic Role of Prior Heart Failure Hospitalization Among Patients Hospitalized for Worsening Chronic Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e007871. doi: 10.1161/CIRCHEARTFAILURE.120.007871. Epub 2021 Mar 29.

  • Greene SJ, DeVore AD, Sheng S, Fonarow GC, Butler J, Califf RM, Hernandez AF, Matsouaka RA, Samman Tahhan A, Thomas KL, Vaduganathan M, Yancy CW, Peterson ED, O'Connor CM, Mentz RJ. Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF. JACC Heart Fail. 2019 Nov;7(11):980-992. doi: 10.1016/j.jchf.2019.07.011. Epub 2019 Oct 9.

  • Greene SJ, Hernandez AF, Sun JL, Butler J, Armstrong PW, Ezekowitz JA, Zannad F, Ferreira JP, Coles A, Metra M, Voors AA, Califf RM, O'Connor CM, Mentz RJ. Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points. Circ Cardiovasc Qual Outcomes. 2018 Oct;11(10):e004783. doi: 10.1161/CIRCOUTCOMES.118.004783.

  • Verma AK, Sun JL, Hernandez A, Teerlink JR, Schulte PJ, Ezekowitz J, Voors A, Starling R, Armstrong P, O'Conner CM, Mentz RJ. Rate pressure product and the components of heart rate and systolic blood pressure in hospitalized heart failure patients with preserved ejection fraction: Insights from ASCEND-HF. Clin Cardiol. 2018 Jul;41(7):945-952. doi: 10.1002/clc.22981. Epub 2018 Jul 17.

  • Bhatt AS, Cooper LB, Ambrosy AP, Clare RM, Coles A, Joyce E, Krishnamoorthy A, Butler J, Felker GM, Ezekowitz JA, Armstrong PW, Hernandez AF, O'Connor CM, Mentz RJ. Interaction of Body Mass Index on the Association Between N-Terminal-Pro-b-Type Natriuretic Peptide and Morbidity and Mortality in Patients With Acute Heart Failure: Findings From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). J Am Heart Assoc. 2018 Feb 3;7(3):e006740. doi: 10.1161/JAHA.117.006740.

  • Greene SJ, Hernandez AF, Dunning A, Ambrosy AP, Armstrong PW, Butler J, Cerbin LP, Coles A, Ezekowitz JA, Metra M, Starling RC, Teerlink JR, Voors AA, O'Connor CM, Mentz RJ. Hospitalization for Recently Diagnosed Versus Worsening Chronic Heart Failure: From the ASCEND-HF Trial. J Am Coll Cardiol. 2017 Jun 27;69(25):3029-3039. doi: 10.1016/j.jacc.2017.04.043.

  • Greene SJ, Hernandez AF, Sun JL, Metra M, Butler J, Ambrosy AP, Ezekowitz JA, Starling RC, Teerlink JR, Schulte PJ, Voors AA, Armstrong PW, O'Connor CM, Mentz RJ. Influence of Clinical Trial Site Enrollment on Patient Characteristics, Protocol Completion, and End Points: Insights From the ASCEND-HF Trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). Circ Heart Fail. 2016 Sep;9(9):e002986. doi: 10.1161/CIRCHEARTFAILURE.116.002986.

  • Ezekowitz JA, Podder M, Hernandez AF, Armstrong PW, Starling RC, O'Connor CM, Califf RM. Arrival by ambulance in acute heart failure: insights into the mode of presentation from Acute Studies of Nesiritide in Decompensated Heart Failure (ASCEND-HF). BMJ Open. 2016 Mar 17;6(3):e010201. doi: 10.1136/bmjopen-2015-010201.

  • Abualnaja S, Podder M, Hernandez AF, McMurray JJ, Starling RC, O'Connor CM, Califf RM, Armstrong PW, Ezekowitz JA. Acute Heart Failure and Atrial Fibrillation: Insights From the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) Trial. J Am Heart Assoc. 2015 Aug 24;4(8):e002092. doi: 10.1161/JAHA.115.002092.

  • Patel PA, Heizer G, O'Connor CM, Schulte PJ, Dickstein K, Ezekowitz JA, Armstrong PW, Hasselblad V, Mills RM, McMurray JJ, Starling RC, Tang WH, Califf RM, Hernandez AF. Hypotension during hospitalization for acute heart failure is independently associated with 30-day mortality: findings from ASCEND-HF. Circ Heart Fail. 2014 Nov;7(6):918-25. doi: 10.1161/CIRCHEARTFAILURE.113.000872. Epub 2014 Oct 3.

  • van Deursen VM, Hernandez AF, Stebbins A, Hasselblad V, Ezekowitz JA, Califf RM, Gottlieb SS, O'Connor CM, Starling RC, Tang WH, McMurray JJ, Dickstein K, Voors AA. Nesiritide, renal function, and associated outcomes during hospitalization for acute decompensated heart failure: results from the Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure (ASCEND-HF). Circulation. 2014 Sep 16;130(12):958-65. doi: 10.1161/CIRCULATIONAHA.113.003046. Epub 2014 Jul 29.

  • Kaul P, Reed SD, Hernandez AF, Howlett JG, Ezekowitz JA, Li Y, Zheng Y, Rouleau JL, Starling RC, O'Connor CM, Califf RM, Armstrong PW. Differences in treatment, outcomes, and quality of life among patients with heart failure in Canada and the United States. JACC Heart Fail. 2013 Dec;1(6):523-30. doi: 10.1016/j.jchf.2013.07.004. Epub 2013 Oct 23.

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  • Reed SD, Kaul P, Li Y, Eapen ZJ, Davidson-Ray L, Schulman KA, Massie BM, Armstrong PW, Starling RC, O'Connor CM, Hernandez AF, Califf RM. Medical resource use, costs, and quality of life in patients with acute decompensated heart failure: findings from ASCEND-HF. J Card Fail. 2013 Sep;19(9):611-20. doi: 10.1016/j.cardfail.2013.07.003.

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  • Eapen ZJ, Reed SD, Li Y, Kociol RD, Armstrong PW, Starling RC, McMurray JJ, Massie BM, Swedberg K, Ezekowitz JA, Fonarow GC, Teerlink JR, Metra M, Whellan DJ, O'Connor CM, Califf RM, Hernandez AF. Do countries or hospitals with longer hospital stays for acute heart failure have lower readmission rates?: Findings from ASCEND-HF. Circ Heart Fail. 2013 Jul;6(4):727-32. doi: 10.1161/CIRCHEARTFAILURE.112.000265. Epub 2013 Jun 14.

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  • O'Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJ, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalan R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Mendez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Tang WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32-43. doi: 10.1056/NEJMoa1100171.

Related Links

MeSH Terms

Conditions

Heart FailureDyspnea

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Limitations and Caveats

Only summary counts of deaths by group are provided for other pre-specified endpoints "All-cause mortality through Day 30" and "All-cause mortality through Day 180." Formal statistical comparisons were not planned.

Results Point of Contact

Title
Vice President, Franchise Development
Organization
Johnson & Johnson Pharmaceutical Research & Development, LLC

Study Officials

  • Scios, Inc. Clinical Trial

    Scios, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 21, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 8, 2013

Results First Posted

May 10, 2012

Record last verified: 2013-03

Locations