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


Tracking Information

Start Date  ICMJEMay 2007
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: February 14, 2008)
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. [ Time Frame: Rehospitalization due to heart failure and all-cause mortality from randomization through Day 30 and dyspnea symptoms at 6 hours or 24 hours after study drug initiation. ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: May 18, 2007)
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.
Change HistoryComplete list of historical versions of study NCT00475852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 14, 2008)
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 [ Time Frame: Overall well-being at 6 hours or 24 hours after study drug initiation. The number of days alive and outside the hospital from randomization through Day 30 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: May 18, 2007)
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

Descriptive Information

Brief Title  ICMJEA Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
Official Title  ICMJEDouble-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)
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 readmissions to hospitals, and helps patients live longer.

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 i.v. (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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEHeart Decompensation
Intervention  ICMJE
  • 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
Study Arms / Comparison Groups
  • 001: Experimental
    Nesiritide 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
    Intervention: 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
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE7000
Estimated Completion DateJune 2010
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hospitalized for the management of 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)
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:info1@veritasmedicine.com
Location Countries  ICMJEUnited 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,   Romania,   Russian Federation,   Singapore,   Sweden,   Taiwan,   Thailand,   Ukraine

Administrative Information

NCT ID  ICMJENCT00475852
Responsible PartyVice President, Associate Therapeutic Area Head, Scios RD, Inc.
Study ID Numbers  ICMJECR013954, NATRECORAHF3002, ASCEND-HF, A093
Study Sponsor  ICMJEScios, Inc.
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Scios, Inc. Clinical TrialScios, Inc.
Information Provided ByScios, Inc.