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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
Results First Received: September 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Heart Decompensation
Interventions: Drug: Nesiritide
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)

Reporting Groups
  Description
Nesiritide 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Placebo Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Participant Flow:   Overall Study
    Nesiritide   Placebo
STARTED   3564   3577 
COMPLETED   3047   3029 
NOT COMPLETED   517   548 
Death                444                456 
Withdrawal by Subject                19                24 
Lost to Follow-up                54                68 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nesiritide 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Placebo Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Total Total of all reporting groups

Baseline Measures
   Nesiritide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 3564   3577   7141 
Age 
[Units: Participants]
     
<=18 years   4   2   6 
Between 18 and 65 years   1572   1597   3169 
>=65 years   1988   1978   3966 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.5  (14.09)   65.4  (14.20)   65.5  (14.14) 
Age, Customized 
[Units: Participants]
     
<=64   1576   1599   3175 
65-74   938   901   1839 
>=75   1050   1077   2127 
Gender 
[Units: Participants]
     
Female   1197   1247   2444 
Male   2367   2330   4697 
Region of Enrollment 
[Units: Participants]
     
ARG   108   108   216 
AUS   18   16   34 
BGR   35   32   67 
BRA   73   77   150 
CAN   240   236   476 
CHL   25   25   50 
CHN   154   160   314 
COL   15   15   30 
DEU   3   3   6 
FRA   51   47   98 
GRC   24   24   48 
IND   499   502   1001 
ISR   38   40   78 
ITA   36   36   72 
KOR   74   74   148 
LTU   48   49   97 
MEX   108   111   219 
MYS   38   37   75 
NLD   71   70   141 
NOR   27   29   56 
NZL   7   7   14 
POL   134   133   267 
ROU   24   28   52 
RUS   148   147   295 
SGP   27   26   53 
SWE   2   3   5 
THA   23   23   46 
TWN   38   39   77 
UKR   97   92   189 
USA   1379   1388   2767 
Baseline BMI 
[Units: Kg/cm2]
Mean (Standard Deviation)
 28.9  (7.86)   29.1  (7.77)   29.0  (7.81) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality   [ Time Frame: Randomization to Day 30 ]

2.  Primary:   Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug   [ Time Frame: 6 hours after initiation of study drug ]

3.  Primary:   Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug   [ Time Frame: 24 hours after study drug initiation ]

4.  Secondary:   Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug   [ Time Frame: 6 hours after study drug initiation ]

5.  Secondary:   Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug   [ Time Frame: 24 hours after study drug initiation ]

6.  Secondary:   Composite of Persistent or Worsening Heart Failure and All-Cause Mortality   [ Time Frame: Randomization to hospital discharge (up to Day 30) ]

7.  Secondary:   Number of Days Alive and Outside the Hospital   [ Time Frame: Randomization to Day 30 ]

8.  Secondary:   Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality   [ Time Frame: Randomization to Day 30 ]

9.  Other Pre-specified:   All-Cause Mortality Through Day 30   [ Time Frame: Randomization to Day 30 ]

10.  Other Pre-specified:   All-Cause Mortality Through Day 180   [ Time Frame: Randomization to Day 180 ]

11.  Other Pre-specified:   Cardiovascular Mortality Through Day 30   [ Time Frame: Randomization to Day 30 ]

12.  Other Pre-specified:   Number of Patients With Renal Impairment   [ Time Frame: Study drug initiation to Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only summary counts of deaths by group are provided for other pre-specified endpoints “All-cause mortality through Day 30” and “All-cause mortality through Day 180.” Formal statistical comparisons were not planned.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Franchise Development
Organization: Johnson & Johnson Pharmaceutical Research & Development, LLC
phone: 610-651-6628


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
O'Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJ, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalán R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Méndez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Tang WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32-43. doi: 10.1056/NEJMoa1100171. Erratum in: N Engl J Med. 2011 Aug 25;365(8):773. Wilson, W H [corrected to Tang, W H W].


Responsible Party: Scios, Inc.
ClinicalTrials.gov Identifier: NCT00475852     History of Changes
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 )
Study First Received: May 18, 2007
Results First Received: September 27, 2011
Last Updated: March 1, 2013