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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Heart Decompensation
Interventions: Drug: Nesiritide
Drug: Placebo

  Participant Flow
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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  
Number of Participants  
[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
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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


  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.


Limitations and Caveats
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.  


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


No publications provided by Scios, Inc.

Publications automatically indexed to this study:
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, A093, NATRECORAHF3002
Study First Received: May 18, 2007
Results First Received: September 27, 2011
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration
Lithuania: State Medicine Control Agency - Ministry of Health
Romania: National Medicines Agency
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health