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A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
This study is currently recruiting participants.
Verified by Scios, Inc., December 2008
Sponsored by: Scios, Inc.
Information provided by: Scios, Inc.
ClinicalTrials.gov Identifier: NCT00475852
  Purpose

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.


Condition Intervention Phase
Heart Decompensation
Drug: Placebo
Drug: Nesiritide
Phase III

MedlinePlus related topics: Breathing Problems Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)

Further study details as provided by Scios, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 7000
Study Start Date: May 2007
Estimated Study Completion Date: June 2011
Arms Assigned Interventions
001: Experimental Drug: Nesiritide
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
002: Placebo Comparator Drug: Placebo
matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475852

Contacts
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

  Show 432 Study Locations
Sponsors and Collaborators
Scios, Inc.
Investigators
Study Director: Scios, Inc. Clinical Trial Scios, Inc.
  More Information

To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Scios RD, Inc. ( Vice President, Associate Therapeutic Area Head )
Study ID Numbers: CR013954, NATRECORAHF3002, ASCEND-HF, A093
Study First Received: May 18, 2007
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00475852  
Health Authority: United States: Food and Drug Administration

Keywords provided by Scios, Inc.:
heart failure
Dyspnea
ADHF
nesiritide
decompensated

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Dyspnea

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009