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

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)
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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 |
- Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality [ Time Frame: Randomization to Day 30 ]
- 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.)
- 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.)
- 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.)
- 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.)
- 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.
- Number of Days Alive and Outside the Hospital [ Time Frame: Randomization to Day 30 ]
- Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality [ Time Frame: Randomization to Day 30 ]
- All-Cause Mortality Through Day 30 [ Time Frame: Randomization to Day 30 ]All deaths were adjudicated by an independent Clinical Events Committee.
- All-Cause Mortality Through Day 180 [ Time Frame: Randomization to Day 180 ]All deaths were adjudicated by an independent Clinical Events Committee.
- 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.
- 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.

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

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

Study Director: | Scios, Inc. Clinical Trial | Scios, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Heart Decompensation Dyspnea Heart failure |
Nesiritide Decompensated ADHF |
Heart Failure Heart Diseases Cardiovascular Diseases |
Natriuretic Peptide, Brain Natriuretic Agents Physiological Effects of Drugs |