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

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.

Study Overview

• Status: Completed
• Conditions: Heart Decompensation
• Intervention / Treatment: Drug: Nesiritide; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 7141
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
  • Buenos Aires N/A, Argentina
  • Cordoba, Argentina
  • La Plata, Argentina
  • Mar Del Plata, Argentina
  • Santa Fe, Argentina
  • Tucuman, Argentina
• Australia
  • Bedford, Australia
  • Camperdown N/A, Australia
  • Concord, Australia
  • Darlinghurst, Australia
  • Elizabeth Vale, Australia
  • Fitzroy, Australia
  • Hobart, Australia
  • Kogarah, Australia
  • Launceston, Australia
  • Melbourne, Australia
  • Randwick, Australia
• Brazil
  • Belo Horizonte, Brazil
  • Campinas, Brazil
  • Curitiba, Brazil
  • Fortaleza, Brazil
  • Goiânia, Brazil
  • Porto Alegre, Brazil
  • Recife, Brazil
  • Rio De Janeiro-Rj, Brazil
  • Salvador, Brazil
  • Sao Jose Do Rio Preto, Brazil
  • Sao Paulo, Brazil
  • São José Do Rio Preto, Brazil
• Bulgaria
  • Pleven, Bulgaria
  • Sofia, Bulgaria
  • Varna, Bulgaria
• Canada
  • Alberta
    • Calgary, Alberta, Canada
    • Edmonton, Alberta, Canada
    • Red Deer, Alberta, Canada
  • British Columbia
    • Campbell River, British Columbia, Canada
    • Kelowna, British Columbia, Canada
    • Maple Ridge, British Columbia, Canada
    • New Westminster, British Columbia, Canada
    • Surrey, British Columbia, Canada
    • Vancouver, British Columbia, Canada
    • Victoria, British Columbia, Canada
  • Manitoba
    • Lakeland, Manitoba, Canada
    • Winnipeg, Manitoba, Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
  • Ontario
    • Ajax, Ontario, Canada
    • Brampton, Ontario, Canada
    • Cornwall, Ontario, Canada
    • Hamilton, Ontario, Canada
    • Kitchener, Ontario, Canada
    • Ottawa, Ontario, Canada
    • Scarborough, Ontario, Canada
    • Toronto, Ontario, Canada
  • Quebec
    • Granby, Quebec, Canada
    • Laval, Quebec, Canada
    • Montreal, Quebec, Canada
    • Saint-Charles-Borromee, Quebec, Canada
    • Sherbrooke, Quebec, Canada
    • Ste-Foy, Quebec, Canada
    • Terrebonne, Quebec, Canada
• Chile
  • Santiago, Chile
  • Santiago Rm, Chile
  • Temuco, Chile
• China
  • Beijing, China
  • Beijing Prc, China
  • Guangdong Province, China
  • Hangzhou, China
  • Jinan, China
  • Shanghai, China
  • Tianjin, China
  • Xian, China
• Colombia
  • Barranquilla, Colombia
  • Bogotá Dc, Colombia
  • Floridablanca, Colombia
• France
  • Colmar, France
  • Paris, France
  • Poitiers, France
  • Pontoise, France
  • Thionville Cedex N/A, France
  • Toulouse, France
  • Valenciennes, France
  • Vandoeuvre Les Nancy Cedex, France
• Germany
  • Bad Krozingen, Germany
  • Berlin, Germany
  • Brandenburg, Germany
  • Ludwigshafen, Germany
  • Lüdenscheid, Germany
  • Neuruppin, Germany
• Greece
  • Athens, Greece
  • Larisa, Greece
  • Thessalonikis, Greece
  • Volos, Greece
• India
  • Ahmedabad, India
  • Bangalore N/A, India
  • Coimbatore, India
  • Hyderabad, India
  • Nagpur, India
  • Pune, India
  • Vadodara, India
• Israel
  • Hadera, Israel
  • Haifa, Israel
  • Holon, Israel
  • Petah Tikva, Israel
  • Ramat Gan, Israel
  • Safed, Israel
• Korea, Republic of
  • Chungcheongbuk-Do, Korea, Republic of
  • Seoul, Korea, Republic of
• Lithuania
  • Kaunas, Lithuania
  • Vilnius Lt, Lithuania
• Malaysia
  • Johor Bahru, Malaysia
  • Kuala Lumpur, Malaysia
  • Kuala Lumpur N/A, Malaysia
• Mexico
  • Aguascalientes, Mexico
  • Guadalajara, Mexico
  • San Luis Potosi, Mexico
  • Sinaloa, Mexico
  • Zapopan, Mexico
• Netherlands
  • Amersfoort, Netherlands
  • Delft, Netherlands
  • Gorinchem, Netherlands
  • Groningen, Netherlands
  • Leeuwarden, Netherlands
  • Sneek, Netherlands
• New Zealand
  • Auckland, New Zealand
  • Christchurch, New Zealand
  • Hamilton, New Zealand
  • Hastings, New Zealand
  • Lower Hutt, New Zealand
  • Nelson, New Zealand
• Norway
  • Stavanger, Norway
  • Trondheim, Norway
  • Tønsberg, Norway
• Poland
  • Bydgoszcz, Poland
  • Gdynia, Poland
  • Krakow, Poland
  • Ostrowiec Swietokrzyski, Poland
  • Skierniewice, Poland
  • Warszawa, Poland
  • Wroclaw, Poland
• Russian Federation
  • Ekaterinburg, Russian Federation
  • Kemerovo, Russian Federation
  • Moscow, Russian Federation
  • Tomsk, Russian Federation
  • Tumen, Russian Federation
• Singapore
  • Singapore, Singapore
• Sweden
  • Falun, Sweden
  • Uppsala, Sweden
• Taiwan
  • Kaohsiung, Taiwan
  • Taipei, Taiwan
  • Tao-Yuan, Taiwan
• Thailand
  • Bangkok, Thailand
  • Khon Kaen, Thailand
• Ukraine
  • Dnepropetrovsk, Ukraine
  • Donetsk, Ukraine
  • Kharkov, Ukraine
  • Lviv, Ukraine
  • Nikolaev, Ukraine
  • Vinnitsa, Ukraine
  • Zaporozhye, Ukraine
• United States
  • Alabama
    • Huntsville, Alabama, United States
    • Mobile, Alabama, United States
  • Alaska
    • Anchorage, Alaska, United States
  • Arizona
    • Gilbert, Arizona, United States
    • Scottsdale, Arizona, United States
  • Arkansas
    • Fort Smith, Arkansas, United States
    • Jonesboro, Arkansas, United States
  • California
    • Berkeley, California, United States
    • Culver City, California, United States
    • Escondido, California, United States
    • Inglewood, California, United States
    • Loma Linda, California, United States
    • Los Angeles, California, United States
    • Mission Viejo, California, United States
    • Sacramento, California, United States
    • San Diego, California, United States
    • Santa Ana, California, United States
    • Torrance, California, United States
    • Ventura, California, United States
  • Colorado
    • Denver, Colorado, United States
    • Englewood, Colorado, United States
    • Fort Collins, Colorado, United States
  • Connecticut
    • Hartford, Connecticut, United States
    • New Haven, Connecticut, United States
  • Delaware
    • Newark, Delaware, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Clearwater, Florida, United States
    • Fort Lauderdale, Florida, United States
    • Gainesville, Florida, United States
    • Inverness, Florida, United States
    • Lakeland, Florida, United States
    • Melbourne, Florida, United States
    • Miami Beach, Florida, United States
    • Ocala, Florida, United States
    • Orlando, Florida, United States
    • Tallahassee, Florida, United States
    • Tampa, Florida, United States
    • Winter Haven, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Augusta, Georgia, United States
    • Gainesville, Georgia, United States
    • Macon, Georgia, United States
  • Illinois
    • Aurora, Illinois, United States
    • Chicago, Illinois, United States
    • Downers Grove, Illinois, United States
    • Elk Grove Village, Illinois, United States
    • Hinsdale, Illinois, United States
    • La Grange, Illinois, United States
    • Maywood, Illinois, United States
    • Mokena, Illinois, United States
    • Oakbrook Terrace, Illinois, United States
    • Peoria, Illinois, United States
    • Rockford, Illinois, United States
    • Springfield, Illinois, United States
  • Indiana
    • Anderson, Indiana, United States
    • Indianapolis, Indiana, United States
    • Munster, Indiana, United States
    • South Bend, Indiana, United States
    • Valparaiso, Indiana, United States
  • Kentucky
    • Danville, Kentucky, United States
    • Edgewood, Kentucky, United States
    • Lexington, Kentucky, United States
    • Owensboro, Kentucky, United States
  • Maryland
    • Baltimore, Maryland, United States
    • Randallstown, Maryland, United States
    • Rockville, Maryland, United States
  • Massachusetts
    • Boston, Massachusetts, United States
    • Brighton, Massachusetts, United States
    • Springfield, Massachusetts, United States
    • Worcester, Massachusetts, United States
  • Michigan
    • Bay City, Michigan, United States
    • Detroit, Michigan, United States
    • Flint, Michigan, United States
    • Lansing, Michigan, United States
    • Monroe, Michigan, United States
    • Petoskey, Michigan, United States
    • Pontiac, Michigan, United States
    • Saginaw, Michigan, United States
    • Troy, Michigan, United States
  • Minnesota
    • Minneapolis, Minnesota, United States
  • Mississippi
    • Tupelo, Mississippi, United States
  • Missouri
    • Kansas City, Missouri, United States
    • Saint Louis, Missouri, United States
    • Springfield, Missouri, United States
  • Nebraska
    • Lincoln, Nebraska, United States
    • Omaha, Nebraska, United States
    • Papillion, Nebraska, United States
  • New Hampshire
    • Manchester, New Hampshire, United States
  • New Jersey
    • Brown Mills, New Jersey, United States
    • Camden, New Jersey, United States
    • Elmer, New Jersey, United States
    • Hackensack, New Jersey, United States
    • Neptune, New Jersey, United States
    • Newark, New Jersey, United States
    • Paterson, New Jersey, United States
    • Ridgewood, New Jersey, United States
    • Toms River, New Jersey, United States
    • Trenton, New Jersey, United States
    • Turnersville, New Jersey, United States
  • New York
    • Albany, New York, United States
    • Bronx, New York, United States
    • Brooklyn, New York, United States
    • Elmhurst, New York, United States
    • Johnson City, New York, United States
    • New Hyde Parke, New York, United States
    • Poughkeepsie, New York, United States
    • Rochester, New York, United States
    • Roslyn, New York, United States
    • Saratoga Springs, New York, United States
    • Stony Brook, New York, United States
    • Valhalla, New York, United States
  • North Carolina
    • Asheville, North Carolina, United States
    • Chapel Hill, North Carolina, United States
    • Charlotte, North Carolina, United States
    • Durham, North Carolina, United States
    • Gastonia, North Carolina, United States
    • Greenville, North Carolina, United States
    • Winston Salem, North Carolina, United States
  • Ohio
    • Akron, Ohio, United States
    • Canton, Ohio, United States
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
    • Columbus, Ohio, United States
    • Dayton, Ohio, United States
    • Garfield Heights, Ohio, United States
    • Mansfield, Ohio, United States
    • Mayfield Heights, Ohio, United States
    • Middletown, Ohio, United States
    • Sylvania, Ohio, United States
    • Toledo, Ohio, United States
    • Youngstown, Ohio, United States
  • Oklahoma
    • Midwest City, Oklahoma, United States
    • Oklahoma City, Oklahoma, United States
    • Tulsa, Oklahoma, United States
  • Oregon
    • Bend, Oregon, United States
  • Pennsylvania
    • Abington, Pennsylvania, United States
    • Allentown, Pennsylvania, United States
    • Beaver, Pennsylvania, United States
    • Bethlehem, Pennsylvania, United States
    • Camp Hill, Pennsylvania, United States
    • Danville, Pennsylvania, United States
    • Harrisburg, Pennsylvania, United States
    • Lancaster, Pennsylvania, United States
    • Natrona Heights, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
    • Pittsburgh, Pennsylvania, United States
    • York, Pennsylvania, United States
  • South Carolina
    • Anderson, South Carolina, United States
    • Charleston, South Carolina, United States
    • Greenville, South Carolina, United States
    • Spartanburg, South Carolina, United States
    • Sumter, South Carolina, United States
  • South Dakota
    • Rapid City, South Dakota, United States
  • Tennessee
    • Kingsport, Tennessee, United States
    • Memphis, Tennessee, United States
    • Nashville, Tennessee, United States
    • Oak Ridge, Tennessee, United States
  • Texas
    • Amarillo, Texas, United States
    • Dallas, Texas, United States
    • Fort Worth, Texas, United States
    • Houston, Texas, United States
    • Tyler, Texas, United States
  • Virginia
    • Falls Church, Virginia, United States
    • Harrisonburg, Virginia, United States
    • Lynchburg, Virginia, United States
    • Norfolk, Virginia, United States
    • Winchester, Virginia, United States
  • Washington
    • Tacoma, Washington, United States
  • Wisconsin
    • Burlington, Wisconsin, United States
    • Madison, Wisconsin, United States
    • Milwaukee, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)	Drug: Nesiritide; 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Placebo Comparator: 002; 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; matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	6 hours after study drug initiation
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.)	24 hours after study drug initiation
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality Through Day 30	All deaths were adjudicated by an independent Clinical Events Committee.	Randomization to Day 30
All-Cause Mortality Through Day 180	All deaths were adjudicated by an independent Clinical Events Committee.	Randomization to Day 180
Cardiovascular Mortality Through Day 30	All deaths were adjudicated by an independent Clinical Events Committee (CEC) and the cardiovascular deaths were classified by the CEC based on the primary causes.	Randomization to Day 30
Number of Patients With Renal Impairment	Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.	Study drug initiation to Day 30

Collaborators and Investigators

• Sponsor: Scios, Inc.

Publications and helpful links

General Publications

• Cosiano MF, Vista A, Sun JL, Alhanti B, Harrington J, Butler J, Starling R, Mentz RJ, Greene SJ. Comparing New York Heart Association Class and Patient-Reported Outcomes Among Patients Hospitalized for Heart Failure. Circ Heart Fail. 2022 Oct 31. doi: 10.1161/CIRCHEARTFAILURE.122.010107. Online ahead of print.
• 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.
• Toma M, Ezekowitz JA, Bakal JA, O'Connor CM, Hernandez AF, Sardar MR, Zolty R, Massie BM, Swedberg K, Armstrong PW, Starling RC. The relationship between left ventricular ejection fraction and mortality in patients with acute heart failure: insights from the ASCEND-HF Trial. Eur J Heart Fail. 2014 Mar;16(3):334-41. doi: 10.1002/ejhf.19. Epub 2013 Dec 14.
• 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.
• Howlett JG, Ezekowitz JA, Podder M, Hernandez AF, Diaz R, Dickstein K, Dunlap ME, Corbalan R, Armstrong PW, Starling RC, O'Connor CM, Califf RM, Fonarow GC; ASCEND-HF Investigators. Global variation in quality of care among patients hospitalized with acute heart failure in an international trial: findings from the acute study clinical effectiveness of nesiritide in decompensated heart failure trial (ASCEND-HF). Circ Cardiovasc Qual Outcomes. 2013 Sep 1;6(5):534-42. doi: 10.1161/CIRCOUTCOMES.113.000119. Epub 2013 Jul 30.
• 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.
• Ezekowitz JA, Hu J, Delgado D, Hernandez AF, Kaul P, Leader R, Proulx G, Virani S, White M, Zieroth S, O'Connor C, Westerhout CM, Armstrong PW. Acute heart failure: perspectives from a randomized trial and a simultaneous registry. Circ Heart Fail. 2012 Nov;5(6):735-41. doi: 10.1161/CIRCHEARTFAILURE.112.968974. Epub 2012 Oct 2.
• Ezekowitz JA, Hernandez AF, O'Connor CM, Starling RC, Proulx G, Weiss MH, Bakal JA, Califf RM, McMurray JJ, Armstrong PW. Assessment of dyspnea in acute decompensated heart failure: insights from ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) on the contributions of peak expiratory flow. J Am Coll Cardiol. 2012 Apr 17;59(16):1441-8. doi: 10.1016/j.jacc.2011.11.061.
• 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. Erratum In: N Engl J Med. 2011 Aug 25;365(8):773. Wilson, W H [corrected to Tang, W H W].

Helpful Links

• A study testing the effectiveness of Nesiritide in Patients with Acute Decompensated Heart Failure

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: May 18, 2007
• First Submitted That Met QC Criteria: May 18, 2007
• First Posted (Estimate): May 21, 2007

Study Record Updates

• Last Update Posted (Estimate): March 8, 2013
• Last Update Submitted That Met QC Criteria: March 1, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Heart failure; Nesiritide; Dyspnea; ADHF; Heart Decompensation; Decompensated
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Natriuretic Agents; Natriuretic Peptide, Brain
• Other Study ID Numbers: CR013954; ASCEND-HF (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, LLC); A093 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, LLC); NATRECORAHF3002 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, LLC)