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

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ClinicalTrials.gov Identifier: NCT00475852
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : May 10, 2012
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Scios, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Decompensation Drug: Nesiritide Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)
Study Start Date : May 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality [ Time Frame: Randomization to Day 30 ]
  2. Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug [ Time Frame: 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.)

  3. Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug [ Time Frame: 24 hours after study drug initiation ]
    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.)


Secondary Outcome Measures :
  1. Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug [ Time Frame: 6 hours after study drug initiation ]
    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.)

  2. Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug [ Time Frame: 24 hours after study drug initiation ]
    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.)

  3. Composite of Persistent or Worsening Heart Failure and All-Cause Mortality [ Time Frame: Randomization to hospital discharge (up to Day 30) ]
    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.

  4. Number of Days Alive and Outside the Hospital [ Time Frame: Randomization to Day 30 ]
  5. Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality [ Time Frame: Randomization to Day 30 ]

Other Outcome Measures:
  1. All-Cause Mortality Through Day 30 [ Time Frame: Randomization to Day 30 ]
    All deaths were adjudicated by an independent Clinical Events Committee.

  2. All-Cause Mortality Through Day 180 [ Time Frame: Randomization to Day 180 ]
    All deaths were adjudicated by an independent Clinical Events Committee.

  3. Cardiovascular Mortality Through Day 30 [ Time Frame: Randomization to 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.

  4. Number of Patients With Renal Impairment [ Time Frame: Study drug initiation to Day 30 ]
    Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475852


Locations
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Sponsors and Collaborators
Scios, Inc.
Investigators
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Study Director: Scios, Inc. Clinical Trial Scios, Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, Corbalán 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, Méndez 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].

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Responsible Party: Scios, Inc.
ClinicalTrials.gov Identifier: NCT00475852    
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 )
First Posted: May 21, 2007    Key Record Dates
Results First Posted: May 10, 2012
Last Update Posted: March 8, 2013
Last Verified: March 2013
Keywords provided by Scios, Inc.:
Heart Decompensation
Dyspnea
Heart failure
 Nesiritide
Decompensated
ADHF
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
 Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs