AzTrials
AzTrials

Heart DecompensationPhase 3NCT00475852

A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure

A Phase 3 study testing Nesiritide in people with Heart Decompensation, run by Scios, Inc. at 328 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Decompensation
What is being tested?
Nesiritide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,141 participants
Where
328 sitesin 28 countries
Study dates
May 2007to Mar 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

328 sites in 28 countries.

328 sites in 28 countries

United States171 sites

  • Study site

    Abington, Pennsylvania

  • Study site

    Akron, Ohio

  • Study site

    Albany, New York

  • Study site

    Allentown, Pennsylvania

  • Study site

    Amarillo, Texas

  • Study site

    Anchorage, Alaska

  • Study site

    Anderson, Indiana

  • Study site

    Anderson, South Carolina

  • Study site

    Asheville, North Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Aurora, Illinois

  • Study site

    Baltimore, Maryland

  • Study site

    Bay City, Michigan

  • Study site

    Beaver, Pennsylvania

  • Study site

    Bend, Oregon

  • Study site

    Berkeley, California

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Boston, Massachusetts

  • Study site

    Brighton, Massachusetts

  • Study site

    Brooklyn, New York

  • Study site

    Browns Mills, New Jersey

  • Study site

    Burlington, Wisconsin

  • Study site

    Camden, New Jersey

  • Study site

    Camp Hill, Pennsylvania

  • Study site

    Canton, Ohio

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Culver City, California

  • Study site

    Dallas, Texas

  • Study site

    Danville, Kentucky

  • Study site

    Danville, Pennsylvania

  • Study site

    Dayton, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Downers Grove, Illinois

  • Study site

    Durham, North Carolina

  • Study site

    Edgewood, Kentucky

  • Study site

    Elk Grove Village, Illinois

  • Study site

    Elmer, New Jersey

  • Study site

    Elmhurst, New York

  • Study site

    Englewood, Colorado

  • Study site

    Escondido, California

  • Study site

    Falls Church, Virginia

  • Study site

    Flint, Michigan

  • Study site

    Fort Collins, Colorado

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Smith, Arkansas

  • Study site

    Fort Worth, Texas

  • Study site

    Gainesville, Florida

  • Study site

    Gainesville, Georgia

  • Study site

    Garfield Heights, Ohio

  • Study site

    Gastonia, North Carolina

  • Study site

    Gilbert, Arizona

  • Study site

    Greenville, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Harrisburg, Pennsylvania

  • Study site

    Harrisonburg, Virginia

  • Study site

    Hartford, Connecticut

  • Study site

    Hinsdale, Illinois

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Inglewood, California

  • Study site

    Inverness, Florida

  • Study site

    Johnson City, New York

  • Study site

    Jonesboro, Arkansas

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    La Grange, Illinois

  • Study site

    Lakeland, Florida

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Loma Linda, California

  • Study site

    Los Angeles, California

  • Study site

    Lynchburg, Virginia

  • Study site

    Macon, Georgia

  • Study site

    Madison, Wisconsin

  • Study site

    Manchester, New Hampshire

  • Study site

    Mansfield, Ohio

  • Study site

    Mayfield Heights, Ohio

  • Study site

    Maywood, Illinois

  • Study site

    Melbourne, Florida

  • Study site

    Memphis, Tennessee

  • Study site

    Miami Beach, Florida

  • Study site

    Middletown, Ohio

  • Study site

    Midwest City, Oklahoma

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mission Viejo, California

  • Study site

    Mobile, Alabama

  • Study site

    Mokena, Illinois

  • Study site

    Monroe, Michigan

  • Study site

    Munster, Indiana

  • Study site

    Nashville, Tennessee

  • Study site

    Natrona Heights, Pennsylvania

  • Study site

    Neptune City, New Jersey

  • Study site

    New Haven, Connecticut

  • Study site

    New Hyde Parke, New York

  • Study site

    Newark, Delaware

  • Study site

    Newark, New Jersey

  • Study site

    Norfolk, Virginia

  • Study site

    Oak Ridge, Tennessee

  • Study site

    Oakbrook Terrace, Illinois

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Owensboro, Kentucky

  • Study site

    Papillion, Nebraska

  • Study site

    Paterson, New Jersey

  • Study site

    Peoria, Illinois

  • Study site

    Petoskey, Michigan

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Pontiac, Michigan

  • Study site

    Poughkeepsie, New York

  • Study site

    Randallstown, Maryland

  • Study site

    Rapid City, South Dakota

  • Study site

    Ridgewood, New Jersey

  • Study site

    Rochester, New York

  • Study site

    Rockford, Illinois

  • Study site

    Rockville, Maryland

  • Study site

    Roslyn, New York

  • Study site

    Sacramento, California

  • Study site

    Saginaw, Michigan

  • Study site

    San Diego, California

  • Study site

    Santa Ana, California

  • Study site

    Saratoga Springs, New York

  • Study site

    Scottsdale, Arizona

  • Study site

    South Bend, Indiana

  • Study site

    Spartanburg, South Carolina

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Massachusetts

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    Stony Brook, New York

  • Study site

    Sumter, South Carolina

  • Study site

    Sylvania, Ohio

  • Study site

    Tacoma, Washington

  • Study site

    Tallahassee, Florida

  • Study site

    Tampa, Florida

  • Study site

    The Bronx, New York

  • Study site

    Toledo, Ohio

  • Study site

    Toms River, New Jersey

  • Study site

    Torrance, California

  • Study site

    Trenton, New Jersey

  • Study site

    Troy, Michigan

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tupelo, Mississippi

  • Study site

    Turnersville, New Jersey

  • Study site

    Tyler, Texas

  • Study site

    Valhalla, New York

  • Study site

    Valparaiso, Indiana

  • Study site

    Ventura, California

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Winchester, Virginia

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Haven, Florida

  • Study site

    Worcester, Massachusetts

  • Study site

    York, Pennsylvania

  • Study site

    Youngstown, Ohio

Other trials in United States

Canada28 sites

  • Study site

    Ajax, Ontario

  • Study site

    Brampton, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Campbell River, British Columbia

  • Study site

    Cornwall, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Granby, Quebec

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    Kelowna, British Columbia

  • Study site

    Kitchener, Ontario

  • Study site

    Lakeland, Manitoba

  • Study site

    Laval, Quebec

  • Study site

    Maple Ridge, British Columbia

  • Study site

    Montreal, Quebec

  • Study site

    New Westminster, British Columbia

  • Study site

    Ottawa, Ontario

  • Study site

    Red Deer, Alberta

  • Study site

    Saint-Charles-Borromée, Quebec

  • Study site

    Scarborough Village, Ontario

  • Study site

    Sherbrooke, Quebec

  • Study site

    Ste-Foy, Quebec

  • Study site

    Surrey, British Columbia

  • Study site

    Terrebonne, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Australia11 sites

  • Study site

    Bedford

  • Study site

    Camperdown

  • Study site

    Concord

  • Study site

    Darlinghurst

  • Study site

    Elizabeth Vale

  • Study site

    Fitzroy

  • Study site

    Hobart

  • Study site

    Kogarah

  • Study site

    Launceston

  • Study site

    Melbourne

  • Study site

    Randwick

Other trials in Australia

Brazil11 sites

  • Study site

    Belo Horizonte

  • Study site

    Campinas

  • Study site

    Curitiba

  • Study site

    Fortaleza

  • Study site

    Goiânia

  • Study site

    Porto Alegre

  • Study site

    Recife

  • Study site

    Rio de Janeiro-Rj

  • Study site

    Salvador

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

Other trials in Brazil

China8 sites

  • Study site

    Beijing

  • Study site

    Beijing Prc

  • Study site

    Guangdong Province

  • Study site

    Hangzhou

  • Study site

    Jinan

  • Study site

    Shanghai

  • Study site

    Tianjin

  • Study site

    Xi'an

Other trials in China

France8 sites

  • Study site

    Colmar

  • Study site

    Paris

  • Study site

    Poitiers

  • Study site

    Pontoise

  • Study site

    Thionville Cedex N/A

  • Study site

    Toulouse

  • Study site

    Valenciennes

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

India7 sites

  • Study site

    Ahmedabad

  • Study site

    Bengaluru

  • Study site

    Coimbatore

  • Study site

    Hyderabad

  • Study site

    Nagpur

  • Study site

    Pune

  • Study site

    Vadodara

Other trials in India

Poland7 sites

  • Study site

    Bydgoszcz

  • Study site

    Gdynia

  • Study site

    Krakow

  • Study site

    Ostrowiec Świętokrzyski

  • Study site

    Skierniewice

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Ukraine7 sites

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Lviv

  • Study site

    Mykolayiv

  • Study site

    Vinnitsa

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Argentina6 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    La Plata

  • Study site

    Mar del Plata

  • Study site

    San Miguel de Tucumán

  • Study site

    Santa Fe

Other trials in Argentina

Germany6 sites

  • Study site

    Bad Krozingen

  • Study site

    Berlin

  • Study site

    Brandenburg

  • Study site

    Lüdenscheid

  • Study site

    Ludwigshafen

  • Study site

    Neuruppin

Other trials in Germany

Israel6 sites

  • Study site

    Hadera

  • Study site

    Haifa

  • Study site

    Holon

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Safed

Other trials in Israel

Netherlands6 sites

  • Study site

    Amersfoort

  • Study site

    Delft

  • Study site

    Gorinchem

  • Study site

    Groningen

  • Study site

    Leeuwarden

  • Study site

    Sneek

Other trials in Netherlands

New Zealand6 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Hamilton

  • Study site

    Hastings

  • Study site

    Lower Hutt

  • Study site

    Nelson

Other trials in New Zealand

Mexico5 sites

  • Study site

    Aguascalientes

  • Study site

    Guadalajara

  • Study site

    San Luis Potosí City

  • Study site

    Sinaloa

  • Study site

    Zapopan

Other trials in Mexico

Russia5 sites

  • Study site

    Kemerovo

  • Study site

    Moscow

  • Study site

    Tomsk

  • Study site

    Tyumen

  • Study site

    Yekaterinburg

Other trials in Russia

Greece4 sites

  • Study site

    Athens

  • Study site

    Larissa

  • Study site

    Thessalonikis

  • Study site

    Volos

Other trials in Greece

Bulgaria3 sites

  • Study site

    Pleven

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Chile3 sites

  • Study site

    Santiago

  • Study site

    Santiago Rm

  • Study site

    Temuco

Other trials in Chile

Colombia3 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá Dc

  • Study site

    Floridablanca

Other trials in Colombia

Norway3 sites

  • Study site

    Stavanger

  • Study site

    Tønsberg

  • Study site

    Trondheim

Other trials in Norway

Taiwan3 sites

  • Study site

    Kaohsiung City

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

Lithuania2 sites

  • Study site

    Kaunas

  • Study site

    Vilnius Lt

Other trials in Lithuania

Malaysia2 sites

  • Study site

    Johor Bahru

  • Study site

    Kuala Lumpur

Other trials in Malaysia

South Korea2 sites

  • Study site

    Chungcheongbuk-Do

  • Study site

    Seoul

Other trials in South Korea

Sweden2 sites

  • Study site

    Falun

  • Study site

    Uppsala

Other trials in Sweden

Thailand2 sites

  • Study site

    Bangkok

  • Study site

    Khon Kaen

Other trials in Thailand

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

Official title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)

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.

Read the detailed description

Acute Decompensated Heart Failure (ADHF) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body. This is a randomized (study medication is assigned by chance), double-blind (neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo [does not contain study drug]), placebo-controlled, parallel group, multicenter study of the effectiveness of nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days. The study hypothesis is that nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties (by patient evaluation utilizing a breathlessness scale) at 6 hours or 24 hours after nesiritide administration, and reduction in rehospitalization due to heart failure and death from study drug administration through Day 30. The study drug (nesiritide) or placebo dose being studied is 0.010 mcg/kg/min with or without a 2 mcg/kg initial bolus (one time injection) of nesiritide. Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects. The patients assigned to the nesiritide group will receive a continuous intravenous (into a vein) infusion at 0.010 mcg/kg/min of nesiritide with or without a 2 mcg/kg bolus (one time injection). The patients assigned to the placebo group will receive matching placebo bolus and infusion. The bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days.

Being tested
Nesiritide, Placebo
Keywords
Heart Decompensation, Dyspnea, Heart failure, Nesiritide, Decompensated, ADHF
Medical subject headings
Heart Failure, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NesiritideDrug

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

  • PlaceboDrug

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

Study groups in NCT00475852
Study groupRoleWhat they receive
001ExperimentalNesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)
Receives: Drug: Nesiritide
002Placebo comparatorPlacebo matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Randomization to Day 30

  2. 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.)

    Measured: 6 hours after initiation of study drug

  3. 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.)

    Measured: 24 hours after study drug initiation

Secondary outcomes (5)

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

    Overall well-being was 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.)

    Measured: 6 hours after study drug initiation

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

    Overall well-being was 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.)

    Measured: 24 hours after study drug initiation

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

    Clinical manifestations of worsening or persistent decompensated heart failure were defined by at least one of the following: new, persistent or worsening: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiologic evidence of worsening heart failure. And was also defined by a new therapy specifically for the treatment of worsening or persistent decompensated heart failure.

    Measured: Randomization to hospital discharge (up to Day 30)

  4. Number of Days Alive and Outside the Hospital

    Measured: Randomization to Day 30

  5. Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality

    Measured: Randomization to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7,141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00475852
Sponsor's protocol ID
CR013954
Other IDs
ASCEND-HF, A093, NATRECORAHF3002
Status last verified
Mar 2013
First submitted
18 May 2007
Last updated
8 Mar 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 37725680

  • 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.

    PubMed 36314126

  • 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.

    PubMed 33775110

  • 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.

    PubMed 31606362

  • 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.

    PubMed 30354576

  • 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.

    PubMed 29781109

  • 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.

    PubMed 29431103

  • 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.

    PubMed 28641792

  • 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.

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  • 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.

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  • 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.

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  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nesiritide in people with Heart Decompensation, run by Scios, Inc. at 328 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 328 sites in United States, Canada, Australia, Brazil, China and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality (time frame: Randomization to Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00475852, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.

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