Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction (Believe II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Horng Chen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00573144
First received: December 13, 2007
Last updated: September 2, 2014
Last verified: September 2014
Results First Received: September 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Acute Myocardial Infarction
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
Subjects were recruited at the Mayo Clinic Cardiac Care Units in Rochester, Minnesota and Jacksonville, Florida.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject withdrew consent before randomization.

Reporting Groups
  Description
Placebo Infusion of 72 hours of saline solution (packaged to match active comparator).
Nesiritide Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.

Participant Flow:   Overall Study
    Placebo     Nesiritide  
STARTED     30     28  
COMPLETED     28     25  
NOT COMPLETED     2     3  
Withdrawal by Subject                 2                 3  



  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.
Baseline values are reported for subjects completing the study (28 in placebo group and 25 in nesiritide group).

Reporting Groups
  Description
Placebo Infusion of 72 hours of saline solution (packaged to match active comparator).
Nesiritide Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Total Total of all reporting groups

Baseline Measures
    Placebo     Nesiritide     Total  
Number of Participants  
[units: participants]
  28     25     53  
Age  
[units: years]
Mean ± Standard Deviation
  55.85  ± 11.12     60.4  ± 11.15     58.0  ± 11.26  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     22     17     39  
>=65 years     6     8     14  
Gender  
[units: participants]
     
Female     3     3     6  
Male     25     22     47  
Region of Enrollment  
[units: participants]
     
United States     28     25     53  



  Outcome Measures
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1.  Primary:   Change in Left Ventricular End-Systolic Volume Index   [ Time Frame: baseline, 30 days ]

2.  Secondary:   Change in Left Ventricular End-Systolic Diastolic Volume Index   [ Time Frame: baseline, 30 days ]

3.  Secondary:   Myocardial Infarct Size at 30 Days   [ Time Frame: 30 days ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Horng H. Chen
Organization: Mayo Clinic
phone: 507-284-1644
e-mail: chen.horng@mayo.edu


No publications provided


Responsible Party: Horng Chen, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00573144     History of Changes
Other Study ID Numbers: 06-002180
Study First Received: December 13, 2007
Results First Received: September 2, 2014
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board