Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy (ABC-HFT)
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|ClinicalTrials.gov Identifier: NCT00842023|
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : August 30, 2013
Last Update Posted : August 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Decompensated Heart Failure||Drug: Nesiritide Drug: Nitroglycerin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||February 2009|
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
- Renal Function by Serum Creatinine [ Time Frame: Baseline, 24 hours, 48 hours ]Serum creatinine values and changes in serum creatinine
- Inflammatory Markers [ Time Frame: 48 hours ]Interleukin-6
- Serum Levels of Cystatin-C [ Time Frame: Baseline, 24 hours, 48 hours ]Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842023
|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|