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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scios, Inc.
ClinicalTrials.gov Identifier:
NCT00475852
First received: May 18, 2007
Last updated: March 1, 2013
Last verified: March 2013

May 18, 2007
March 1, 2013
May 2007
March 2011   (final data collection date for primary outcome measure)
  • Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
  • Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug [ Time Frame: 6 hours after initiation of study drug ] [ Designated as safety issue: Yes ]
    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.)
  • Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug [ Time Frame: 24 hours after study drug initiation ] [ Designated as safety issue: Yes ]
    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.)
Rehospitalization due to heart failure and all-cause mortality from randomization through Day 30 and dyspnea symptoms as measured by subject self-assessed Likert scale at 6 hours or 24 hours after study drug initiation.
Complete list of historical versions of study NCT00475852 on ClinicalTrials.gov Archive Site
  • Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug [ Time Frame: 6 hours after study drug initiation ] [ Designated as safety issue: Yes ]
    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.)
  • Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug [ Time Frame: 24 hours after study drug initiation ] [ Designated as safety issue: Yes ]
    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.)
  • Composite of Persistent or Worsening Heart Failure and All-Cause Mortality [ Time Frame: Randomization to hospital discharge (up to Day 30) ] [ Designated as safety issue: Yes ]
    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.
  • Number of Days Alive and Outside the Hospital [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
  • Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
Overall well-being as measured by subject self-assessed Likert scale at 6 hours or 24 hours after study drug initiation. The number of days alive and outside the hospital from randomization through Day 30
  • All-Cause Mortality Through Day 30 [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
    All deaths were adjudicated by an independent Clinical Events Committee.
  • All-Cause Mortality Through Day 180 [ Time Frame: Randomization to Day 180 ] [ Designated as safety issue: Yes ]
    All deaths were adjudicated by an independent Clinical Events Committee.
  • Cardiovascular Mortality Through Day 30 [ Time Frame: Randomization to Day 30 ] [ Designated as safety issue: Yes ]
    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.
  • Number of Patients With Renal Impairment [ Time Frame: Study drug initiation to Day 30 ] [ Designated as safety issue: Yes ]
    Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Decompensation
  • Drug: Nesiritide
    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
  • Experimental: 001
    Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)
    Intervention: Drug: Nesiritide
  • 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
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7141
March 2011
March 2011   (final data collection date for primary outcome measure)

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).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   France,   Germany,   Greece,   India,   Israel,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Russian Federation,   Singapore,   Sweden,   Taiwan,   Thailand,   Ukraine
 
NCT00475852
CR013954, ASCEND-HF, A093, NATRECORAHF3002
No
Scios, Inc.
Scios, Inc.
Not Provided
Study Director: Scios, Inc. Clinical Trial Scios, Inc.
Scios, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP