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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00475852




Registration number
NCT00475852
Ethics application status
Date submitted
18/05/2007
Date registered
21/05/2007
Date last updated
8/03/2013

Titles & IDs
Public title
A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
Scientific title
Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)
Secondary ID [1] 0 0
ASCEND-HF
Secondary ID [2] 0 0
CR013954
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Decompensation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nesiritide
Treatment: Drugs - Placebo

Experimental: 001 - Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (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


Treatment: Drugs: Nesiritide
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Treatment: Drugs: Placebo
matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality
Timepoint [1] 0 0
Randomization to Day 30
Primary outcome [2] 0 0
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.)
Timepoint [2] 0 0
6 hours after initiation of study drug
Primary outcome [3] 0 0
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.)
Timepoint [3] 0 0
24 hours after study drug initiation
Secondary outcome [1] 0 0
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.)
Timepoint [1] 0 0
6 hours after study drug initiation
Secondary outcome [2] 0 0
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.)
Timepoint [2] 0 0
24 hours after study drug initiation
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Randomization to hospital discharge (up to Day 30)
Secondary outcome [4] 0 0
Number of Days Alive and Outside the Hospital
Timepoint [4] 0 0
Randomization to Day 30
Secondary outcome [5] 0 0
Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality
Timepoint [5] 0 0
Randomization to Day 30

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bedford
Recruitment hospital [2] 0 0
- Camperdown N/A
Recruitment hospital [3] 0 0
- Concord
Recruitment hospital [4] 0 0
- Darlinghurst
Recruitment hospital [5] 0 0
- Elizabeth Vale
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Hobart
Recruitment hospital [8] 0 0
- Kogarah
Recruitment hospital [9] 0 0
- Launceston
Recruitment hospital [10] 0 0
- Melbourne
Recruitment hospital [11] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Bedford
Recruitment postcode(s) [2] 0 0
- Camperdown N/A
Recruitment postcode(s) [3] 0 0
- Concord
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- Darlinghurst
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- Elizabeth Vale
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- Fitzroy
Recruitment postcode(s) [7] 0 0
- Hobart
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- Kogarah
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- Launceston
Recruitment postcode(s) [10] 0 0
- Melbourne
Recruitment postcode(s) [11] 0 0
- Randwick
Recruitment outside Australia
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Zaporozhye

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Scios, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00475852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scios, Inc. Clinical Trial
Address 0 0
Scios, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications