Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy (ABC-HFT)
The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered.
Acute Decompensated Heart Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial to Evaluate Renal Function, Inflammatory Mediators, and Neurohormonal Markers in Acutely Decompensated Heart Failure Patients Receiving Nesiritide Compared to Nitroglycerin.|
- Renal Function by Serum Creatinine [ Time Frame: Baseline, 24 hours, 48 hours ] [ Designated as safety issue: Yes ]Serum creatinine values and changes in serum creatinine
- Inflammatory Markers [ Time Frame: 48 hours ] [ Designated as safety issue: No ]Interleukin-6
- Serum Levels of Cystatin-C [ Time Frame: Baseline, 24 hours, 48 hours ] [ Designated as safety issue: No ]Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.
|Study Start Date:||July 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Nesiritide Infusion
Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
Bolus 2 mcg/kg followed by 0.01 mcg/kg/min
Active Comparator: Nitroglycerin Infusion
Nitroglycerin was initiated at 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.
5-10 mcg/min titrating per protocol based on blood pressure
No additional details provided
|United States, California|
|Centinela Hospital Medical Center|
|Inglewood, California, United States, 90301|
|Principal Investigator:||Sheryl L. Chow, PharmD, FCCP, BCPS||Western University of Heatlh Sciences|