Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy (ABC-HFT)

This study has been completed.
Sponsor:
Collaborator:
American College of Clinical Pharmacy
Information provided by (Responsible Party):
Sheryl Chow, Western University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00842023
First received: February 10, 2009
Last updated: August 29, 2013
Last verified: August 2013
Results First Received: February 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Decompensated Heart Failure
Interventions: Drug: Nesiritide
Drug: Nitroglycerin

  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
No text entered.

Reporting Groups
  Description
Nesiritide Infusion 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
Nitroglycerin Infusion 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.

Participant Flow:   Overall Study
    Nesiritide Infusion     Nitroglycerin Infusion  
STARTED     45     44  
COMPLETED     45     44  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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 Infusion 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
Nitroglycerin Infusion 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
Total Total of all reporting groups

Baseline Measures
    Nesiritide Infusion     Nitroglycerin Infusion     Total  
Number of Participants  
[units: participants]
  45     44     89  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19     24     43  
>=65 years     26     20     46  
Age  
[units: years]
Mean ± Standard Deviation
  68.6  ± 14.1     66.8  ± 17.2     67.7  ± 16.7  
Gender  
[units: participants]
     
Female     20     21     41  
Male     25     23     48  
Region of Enrollment [1]
[units: participants]
     
United States     45     44     89  
[1] Sample size was estimated at 90 patients total; however, 1 patient was enrolled twice. Therefore, only 89 patients were enrolled in the primary study.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Renal Function by Serum Creatinine   [ Time Frame: Baseline, 24 hours, 48 hours ]

2.  Other Pre-specified:   Inflammatory Markers   [ Time Frame: 48 hours ]

3.  Other Pre-specified:   Serum Levels of Cystatin-C   [ Time Frame: Baseline, 24 hours, 48 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Dr. Sheryl L. Chow
Organization: Western University of Health Sciences
phone: 9094695379
e-mail: schow@westernu.edu


Publications of Results:

Responsible Party: Sheryl Chow, Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT00842023     History of Changes
Other Study ID Numbers: ACCP-26060
Study First Received: February 10, 2009
Results First Received: February 3, 2012
Last Updated: August 29, 2013
Health Authority: United States: Institutional Review Board